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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Gemphire Therapeutics Inc | NASDAQ:GEMP | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.30 | 0.30 | 0.3169 | 0 | 01:00:00 |
Conference Call & Live Webcast Today at 4:30pm Eastern Time
“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
Upcoming 2018 Clinical Milestones
Fourth Quarter and Fiscal 2017 Financial Update General and administrative expense for the fourth quarter and fiscal year ended December 31, 2017 was $1.5 million and $10.4 million, respectively, compared to $2.4 million and $6.0 million for the fourth quarter and fiscal year ended December 31, 2016, respectively. The increase for the year was primarily attributable to an increase in staffing and professional services associated largely with supporting our clinical trials and becoming a public company in August 2016 together with separation costs incurred in 2017 for our former chief executive officer.
Research and development expense for the fourth quarter and fiscal year ended December 31, 2017 was $5.1 million and $22.7 million, respectively, compared to $4.8 million and $8.7 million for the fourth quarter and fiscal year ended December 31, 2016, respectively. The increase for the year was primarily attributable to increased staffing and fees paid to external service providers for clinical trial development, regulatory consulting, preclinical studies and manufacturing activities to support the clinical advancement of gemcabene.
Net loss attributable to common stockholders for the fourth quarter and fiscal year ended December 31, 2017 was $6.7 million, or ($0.63) per share, and $33.4 million, or ($3.23) per share, respectively, compared to $7.2 million, or ($0.78) per share, and $15.0 million, or ($2.57) per share, for the fourth quarter and fiscal year ended December 31, 2016, respectively.
At December 31, 2017, the company had cash and cash equivalents of approximately $18.5 million. Subsequent to December 31, 2017, the Company raised approximately $23.0 million in net proceeds from a public offering of common stock. Based on the Company’s current operating plans, management believes the current cash on hand will be sufficient to fund operations through completion of the INDIGO-1 Phase2b study in 2018, the initiation of the Phase 3 program in dyslipidemia in the second half of 2018 and the completion of the first of two NASH/NAFLD Phase 2a studies in 2018 and the second in the first half of 2019.
Conference Call and Webcast The call and webcast will take place on Thursday, March 15, at 4:30 pm Eastern Time to participate, please dial (844) 494-0188 (domestic) or +1 (425) 278-9114 (international) and reference conference ID 2090268. The live webcast can be accessed via the following link: https://edge.media-server.com/m6/p/bxoocvxs. A webcast replay will be available on the News & Events section of the Gemphire website for all interested parties following the call and will be archived and available for 90 days.
Gemcabene’s mechanism of action and safety profile are highly differentiated from other clinical candidatesGemphire’s product candidate gemcabene 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 (MOA) 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 of these mechanisms has been clinically observed to result in a reduction of plasma non-HDL-C, VLDL-C, LDL-C, apolipoprotein B and triglycerides. In addition, gemcabene has been shown to markedly lower C-reactive protein in humans and improve insulin sensitization. Gemcabene’s MOA is liver-directed involving downregulation of hepatic apolipoprotein C-III (apoC-III) mRNA expression and decrease of plasma apoC-III levels. Gemcabene has also been shown to reduce liver sulfatase-2 mRNA levels, known to be elevated in diabetic and obese patients. Elevated sulfatase-2 is thought to reduce the effectiveness of the liver VLDL-remnant receptor (also known as Syndecan-1), that normally plays a role in removing triglyceride containing particles from the plasma. Gemcabene also reduces acetyl-CoA carboxylase (ACC1), CCR2/CCR5 receptor and TNF-α mRNA levels, markers thought to be involved in the progression of NASH/NAFLD. Gemcabene has demonstrated POC efficacy for NASH in the rodent STAM™ model developed at SMC Laboratories in Tokyo, Japan. Gemcabene has been tested as monotherapy and in combination with statins and other drugs in nearly 1,100 subjects across 23 Phase 1 and Phase 2 clinical trials. Given this profile of efficacy across multiple pathological pathways, as well as evidence of safety and tolerability, particularly when used as an add-on to many other therapeutic drugs, gemcabene has attributes that support studies in humans for NASH.
About GemphireGemphire 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’s Phase 2 clinical program is evaluating the efficacy and safety of gemcabene in hypercholesterolemia, including FH and ASCVD, SHTG and NASH/NAFLD. Two trials supporting hypercholesterolemia have been completed under NCT02722408 and NCT02634151. Gemphire has completed recruitment for a clinical trial for SHTG under NCT02944383, and has initiated separate trials for adult NASH and pediatric NAFLD. Please visit www.gemphire.com for more information.
Forward Looking Statements Any statements in this press release about Gemphire’s future expectations, milestones, goals, 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, regulatory submissions and meetings and future expectations and plans and prospects for Gemphire, expectations for the future competitive environment for gemcabene, 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: developments in the capital markets, 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; the actions of Gemphire’s competitors; 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 and in other filings Gemphire makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent Gemphire’s views as of the date hereof. Gemphire anticipates that subsequent events and developments will cause Gemphire’s views to change. However, while Gemphire may elect to update these forward-looking statements at some point in the future, Gemphire specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Gemphire’s views as of any date subsequent to the date hereof.
Contact:Andrew McDonald, Ph.D.LifeSci Advisors, LLC(646) 597-6987
Jeff Mathiesen, CFOGemphire Therapeutics Inc.(734)-245-1700
Gemphire Therapeutics Inc.Condensed Statements of Comprehensive Loss(in thousands, except per share amounts) | ||||||||||||||||
Year Ended | Three Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Operating expenses: | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
General and administrative | $ | 10,438 | $ | 5,956 | $ | 1,487 | $ | 2,389 | ||||||||
Research and development | 22,686 | 8,740 | 5,080 | 4,839 | ||||||||||||
Total operating expenses | 33,124 | 14,696 | 6,567 | 7,228 | ||||||||||||
Loss from operations | (33,124 | ) | (14,696 | ) | (6,567 | ) | (7,228 | ) | ||||||||
Interest (expense) income | (286 | ) | 114 | (179 | ) | 13 | ||||||||||
Other (expense) income | (5 | ) | (4 | ) | 1 | |||||||||||
Net loss | $ | (33,415 | ) | $ | (14,586 | ) | $ | (6,746 | ) | $ | (7,214 | ) | ||||
Adjustment to redemption value on Series A convertible preferred stock | — | (366 | ) | -- | -- | |||||||||||
Net loss attributable to common stockholders | $ | (33,415 | ) | $ | (14,952 | ) | $ | (6,746 | ) | $ | (7,214 | ) | ||||
Net loss per share: | ||||||||||||||||
Basic and diluted | $ | (3.23 | ) | $ | (2.57 | ) | $ | (0.63 | ) | $ | (0.78 | ) | ||||
Number of shares used in per share calculations: | ||||||||||||||||
Basic and diluted | 10,349,136 | 5,809,396 | 10,633,042 | 9,264,228 | ||||||||||||
Gemphire Therapeutics Inc.Balance Sheet Data(in thousands) | |||||||
Year Ended | |||||||
December 31, | |||||||
2017 | 2016 | ||||||
(unaudited) | |||||||
Cash and cash equivalents | $ | 18,473 | $ | 24,033 | |||
Total assets | 19,017 | 24,754 | |||||
Term loan (long-term portion) | 8,683 | — | |||||
Total liabilities | 15,076 | 4,122 | |||||
Accumulated deficit | (60,474 | ) | (27,059 | ) | |||
Total stockholders’ equity | 3,941 | 20,632 | |||||
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1 Month Gemphire Therapeutics Chart |
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