We could not find any results for:
Make sure your spelling is correct or try broadening your search.
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 |
Gemcabene reduced LDL-C by 20% and hsCRP by 53% when added to moderate intensity statin therapy
“The third quarter of 2017 was marked by great progress in advancing gemcabene in dyslipidemia and NASH,” said Steven Gullans, Ph.D., interim CEO of Gemphire. “ROYAL-1 was the second of two recent Phase 2b studies to successfully meet its primary endpoint, and new data from ROYAL-1 presented at the American Heart Association meeting have given us further insights into gemcabene’s benefits to patients. We are now preparing for end of Phase 2 meetings for the hypercholesterolemia indications with the FDA and EMA and anticipate that these will take place early in 2018, with the goal of reaching agreement on the overall design of the planned Phase 3 development program. We are also moving forward in NASH, and plan to begin a Phase 2 trial before year end 2017.”
American Heart Association Scientific Sessions 2017
To view the posters, please refer to the Events and Presentations section of the company website.
Third Quarter and Recent Corporate Highlights
Upcoming 2017 and 2018 Clinical Milestones
Third Quarter 2017 Financial Update and Guidance
The primary drivers of the increase in G&A expenses over the prior year third quarter and nine-month periods were increased infrastructure costs to support the ongoing clinical trials and public company requirements, focused primarily in personnel costs, including non-cash equity compensation expense, professional services and separation expenses related to our previous CEO recorded in the second quarter of 2017.
The increase in R&D expense was primarily attributable to increased clinical trial activities encompassing two separate Phase 2b and four separate Phase 1 clinical trials ongoing in the current year period versus minimal expenses related to the initiation of one clinical study in the prior year period.
Cash used in operations in the nine months ended September 30, 2017 was $20.1 million compared to $7.4 million for the nine months ended September 30, 2016.
In July, the Company entered into a term loan agreement for up to $15.0 million with Silicon Valley Bank, subject to funding in several tranches, and immediately drew $10.0 million to extend the cash runway for the ongoing development program for gemcabene. The remaining $5.0 million under the term loan may be drawn, at the Company’s option, subject to the achievement of certain pre-clinical and clinical milestones, through July 31, 2018.
Management expects operating expenses and cash used in operating activities to continue to trend above 2016 levels, primarily in research and development, as the Company funds its ongoing clinical trials and initiates the NASH clinical program. Based on the Company’s current operating plans, management believes existing cash, along with anticipated future proceeds from the July 2017 term loan agreement, is sufficient to fund operations through completion of our remaining dyslipidemia trial as well as completion of the planned NASH clinical trial anticipated to be completed in the second half of 2018 and will support the work to develop our Phase 3 study plans.
Gemcabene’s mechanism of action and safety profile are highly differentiated from other clinical candidates
Gemphire’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 also reduces acetyl-CoA carboxylase (ACC1) and CCR2/CCR5 receptor mRNA levels, markers involved in the progression of non-alcoholic steatohepatitis (NASH)/non-alcoholic fatty liver disease (NAFLD). Gemcabene has demonstrated proof of concept 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 956 subjects across 20 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 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 the fourth quarter 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, regulatory submissions and meetings 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 December 31, 2016, Gemphire’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 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. | ||||||||
Balance Sheet Data | ||||||||
(in thousands) | ||||||||
September 30, | December 31, | |||||||
2017 | 2016 | |||||||
(unaudited) | ||||||||
Cash and cash equivalents | $ | 25,340 | $ | 24,033 | ||||
Total assets | 26,211 | 24,754 | ||||||
Accounts payable and accrued liabilities | 6,295 | 4,121 | ||||||
Term loan | 9,964 | — | ||||||
Total liabilities | 16,262 | 4,122 | ||||||
Common stock | 18 | 17 | ||||||
Additional paid–in capital | 63,659 | 47,674 | ||||||
Accumulated deficit | (53,728) | (27,059) | ||||||
Total stockholders’ equity | 9,949 | 20,632 | ||||||
Condensed Statements of Comprehensive Loss | |||||||||||||
(in thousands, except per share amounts) | |||||||||||||
For the Three MonthsEnded | For the Nine MonthsEnded | ||||||||||||
September 30, | September 30, | ||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||
(unaudited) | (unaudited) | ||||||||||||
Operating expenses: | |||||||||||||
General and administrative | $ | 2,050 | $ | 1,466 | $ | 8,951 | $ | 3,567 | |||||
Research and development | 6,489 | 1,936 | 17,606 | 3,901 | |||||||||
Total operating expenses | 8,539 | 3,402 | 26,557 | 7,468 | |||||||||
Loss from operations | (8,539) | (3,402) | (26,557) | (7,468) | |||||||||
Interest and other income (expense), net | (132) | (476) | (112) | 96 | |||||||||
Net loss | (8,671) | (3,878) | (26,669) | (7,372) | |||||||||
Adjustment to redemption value on Series A convertible preferred stock | — | (67) | — | (366) | |||||||||
Net loss attributable to common stockholders | $ | (8,671) | $ | (3,945) | $ | (26,669) | $ | (7,738) | |||||
Net loss per share: | |||||||||||||
Basic and diluted | $ | (0.82) | $ | (0.56) | $ | (2.60) | $ | (1.65) | |||||
Number of shares used in per share calculations: | |||||||||||||
Basic and diluted | 10,624 | 6,984 | 10,253 | 4,704 | |||||||||
1 Year Gemphire Therapeutics Chart |
1 Month Gemphire Therapeutics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions