Gemphire Announces Second Quarter 2017 Financial Results and Provides Corporate Update
Gemcabene Successful in Phase 2 COBALT-1 HoFH Trial
Gemcabene Hits Primary Endpoint in Phase 2 ROYAL-1 Hypercholesterolemia Trial
“Gemphire successfully met its two major Phase 2 clinical milestones in the last six months demonstrating safety and LDL-C lowering efficacy of gemcabene in patients with HoFH in the COBALT-1 trial and in patients with hypercholesterolemia in the ROYAL-1 trial,” said
“Our strategy is to develop gemcabene in patients who are at high risk for life threatening conditions due to their dyslipidemias despite current therapies. We believe the results of the COBALT-1 and ROYAL-1 trials, combined with the 18 Phase 1 and 2 trials previously completed will provide us with sufficient data to support an end of Phase 2 meeting in 2018 to discuss the company’s gemcabene Phase 3 programs in patients with hypercholesterolemia (ASCVD and HeFH), and HoFH. We are also pursuing the utility of gemcabene in NASH and plan to initiate a Phase 2 clinical trial later in 2017,” concluded Dr. Gullans.
Second Quarter & Recent Corporate and Financial Highlights
- In June, we announced that gemcabene achieved the primary endpoint for LDL cholesterol in our Phase 2b COBALT-1 trial. COBALT-1 evaluated gemcabene in homozygous familial hypercholesterolemia (HoFH) patients who are on stable maximally tolerated lipid-lowering therapies.
- In May, we presented a poster on gemcabene’s mechanism of action based on preclinical findings at the Arteriosclerosis, Thrombosis and Vascular Biology | Peripheral Vascular Disease (ATVB|PVD) 2017 Scientific Sessions. Across the various animal 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).
- In May, we hosted a key opinion leader meeting for investors in
New York featuringDavid E. Cohen , M.D., Ph.D., ofWeill Cornell Medical Institute who discussed the clinical landscape for the treatment of nonalcoholic steatohepatitis (NASH). - In May,
Steven Gullans was appointed as interim president and chief executive officer, following the departure of our former CEO,Mina Sooch . - Cash and cash equivalents at
June 30, 2017 , totaled$22.5 million compared to$24.0 million atDec. 31, 2016 . - Second quarter and six month 2017 results include a
$2.6 million non-recurring compensation expense consisting of$0.5 million of cash compensation and$2.1 million of non-cash compensation resulting from the separation of our former CEO. - In July, we entered into a term loan agreement for up to
$15 million withSilicon Valley Bank , subject to funding in several tranches, and immediately drew$10 million to extend Gemphire’s cash runway for the ongoing development program for gemcabene. The remaining$5 million under the term loan may be drawn, at our option, subject to the achievement of certain pre-clinical and clinical milestones, prior toJuly 31, 2018 . - In August, we announced that gemcabene achieved the primary endpoint for LDL cholesterol in our Phase 2b ROYAL-1 trial. ROYAL-1 evaluated gemcabene in hypercholesterolemic patients on stable high- or moderate-intensity statin and/or ezetimibe therapy.
Upcoming 2017 and 2018 Clinical Milestones
- Additional data from our COBALT-1 and ROYAL-1 trials and communication of continued development plans of gemcabene in HoFH, HeFH and ASCVD are targeted for release in the second half of 2017.
- Top-line results from our INDIGO-1 Phase 2b trial in severe hypertriglyceridemia (SHTG) are targeted for the first quarter of 2018 based on the current pace of enrollment.
- Plan to initiate Phase 2 clinical development program in NASH in the second half of 2017 with top-line results targeted for second half of 2018.
Second Quarter 2017 Financial Update and Guidance
General and administrative expense for the three and six months ended
Research and development expense for the three and six months ended
Net loss attributable to common stockholders for the three and six months ended
Cash used in operations in the six months ended
Management expects operating expenses and cash used in operating activities to continue to trend above 2016 levels, primarily in research and development, as we fund our ongoing clinical trials and initiate our NASH clinical program. Based on the Company’s current operating plans, management believes existing cash, including proceeds from the
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 for NASH in the STAM™ model developed at
About Gemphire
Gemphire is a clinical-stage biopharmaceutical company that is committed to helping patients with cardiometabolic disorders, including dyslipidemia and NASH. The Company is focused on providing new treatment options for cardiometabolic diseases through its 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) |
|||||||||
June 30, | December 31, | ||||||||
2017 | 2016 | ||||||||
(unaudited) |
|||||||||
Cash and cash equivalents | $ | 22,491 | $ | 24,033 | |||||
Total assets | 23,004 | 24,754 | |||||||
Accounts payable and accrued liabilities | 5,272 | 4,121 | |||||||
Total liabilities | 5,274 | 4,122 | |||||||
Common stock | 18 | 17 | |||||||
Additional paid–in capital | 62,769 | 47,674 | |||||||
Accumulated deficit | (45,057 | ) | (27,059 | ) | |||||
Total stockholders’ equity | 17,730 | 20,632 |
Condensed Statements of Comprehensive Loss (in thousands, except per share amounts) |
||||||||||||||||
For the Three Months Ended | For the Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
(unaudited) | (unaudited) | |||||||||||||||
Operating expenses: | ||||||||||||||||
General and administrative | $ | 4,678 | $ | 1,051 | $ | 6,901 | $ | 2,101 | ||||||||
Research and development | 5,837 | 789 | 11,117 | 1,965 | ||||||||||||
Total operating expenses | 10,515 | 1,840 | 18,018 | 4,066 | ||||||||||||
Loss from operations | (10,515 | ) | (1,840 | ) | (18,018 | ) | (4,066 | ) | ||||||||
Interest and other income (expense), net | 13 | 449 | 20 | 572 | ||||||||||||
Net loss | $ | (10,502 | ) | $ | (1,391 | ) | $ | (17,998 | ) | $ | (3,494 | ) | ||||
Adjustment to redemption value on Series A convertible preferred stock | — | (150 | ) | — | (299 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (10,502 | ) | $ | (1,541 | ) | $ | (17,998 | ) | $ | (3,793 | ) | ||||
Net loss per share: | ||||||||||||||||
Basic and diluted | $ | (0.99 | ) | $ | (0.42 | ) | $ | (1.79 | ) | $ | (1.07 | ) | ||||
Number of shares used in per share calculations: | ||||||||||||||||
Basic and diluted | 10,603 | 3,627 | 10,065 | 3,548 |
Contact:Andrew McDonald , Ph.D.LifeSci Advisors, LLC (646) 597-6987Jeff Mathiesen , CFOGemphire Therapeutics Inc. (734)-245-1700