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LIVONIA, Mich., Aug. 13, 2018 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ: GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for cardiometabolic disorders, including dyslipidemia and nonalcoholic steatohepatitis (NASH), today announced financial results for the quarter and six months ended June 30, 2018, and provided a corporate update.
“We capped off our second quarter by announcing that our INDIGO-1 trial investigating gemcabene in severe hypertriglyceridemia (SHTG) patients achieved its primary endpoint,” said Steven Gullans, Ph.D., CEO of Gemphire. “We were pleased to successfully complete our third Phase 2b trial in dyslipidemia and look forward to finalizing our Phase 3 program once we are able to provide the FDA with the additional information they recently requested.”
“While last week’s decision by the Data and Safety Monitoring Board of our primary investigator to terminate the Phase 2a pediatric NAFLD trial will cause us to put our plans to develop gemcabene in this particular population on hold, we remain confident that gemcabene has the potential to be an effective therapy for a host of cardiometabolic patients and we intend to continue to develop gemcabene to address multiple indications.”
Second Quarter 2018 Corporate Highlights
Recent Corporate Developments
Second Quarter 2018 Financial Update
General and administrative expenses for the three and six months ended June 30, 2018 were $2.6 million and $4.7 million, respectively, compared to $4.7 million and $6.9 million, respectively, for the comparable periods of the prior year. The decrease in expenses from the comparable period in 2017 was primarily attributed to $2.1 million of non-cash share-based compensation expense resulting from the acceleration of stock option vesting that occurred in the second quarter of 2017. Timing of costs related to infrastructure supporting our ongoing clinical trials and expenses associated with being a public company were the other primary drivers of the activity during both quarterly periods in 2018 and 2017.
Research and development expenses for the three and six months ended June 30, 2018 were $4.0 million and $8.9 million, respectively, compared to $5.8 million and $11.1 million for the three and six-month periods ended June 30, 2017, respectively. The decrease year over year was primarily attributable to reduced clinical trial activities in the second quarter and first six months of 2018 versus the comparable periods in 2017.
Net loss attributable to common stockholders for the second quarter ended June 30, 2018 was $6.7 million, or ($0.47) per share, compared to $10.5 million, or ($0.99) per share, for the second quarter ended June 30, 2017. Net loss attributable to common stockholders for the six months ended June 30, 2018 was $13.9 million, or ($1.04) per share, compared to $18.0 million, or ($1.79) per share, for the six months ended June 30, 2017.
At June 30, 2018, the company had cash and cash equivalents of approximately $28.0 million. Based on current projections, taking into account the delay of significant cash expenditures for clinical trials and manufacturing and the amended terms of the loan agreement with SVB, the Company believes it has sufficient resources to fund operations into the fourth quarter of 2019.
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’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 and one trial in SHTG have been completed under NCT02722408, NCT02634151 and NCT02944383, respectively. Please visit www.gemphire.com for more information.
Forward Looking Statements
Any statements in this press release that are not statements of historical fact, including statements 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, expected timing of top-line results of such trials, timing and expectations for regulatory submissions and meetings and future expectations and plans and prospects for gemcabene, 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," “promising,” "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: Gemphire’s ability to analyze the results and understand the reasons for the unexpected events in the Phase 2a pediatric NAFLD trial ; the impact of the unexpected events on the Phase 2a study in FPL or the enrollment of patients; that MRI-PDFF scans or other follow-up tests of patients in the pediatric NAFLD, FPL or other trials may show similar increases in liver fat content or ALT or other undesirable side effects; uncertainties inherent in the clinical drug development process and the regulatory approval process, including the risk that gemcabene may cause undesirable side effects or have other properties that could delay or prevent regulatory approval; Gemphire’s substantial dependence on its product candidate, gemcabene; 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.
LifeSci Advisors, LLC
Jeff Mathiesen, CFO
Gemphire Therapeutics Inc.
Gemphire Therapeutics Inc.
Condensed Statements of Comprehensive Loss
(in thousands, except share and per share amounts)
|For the Three Months Ended||For the Six Months Ended|
|June 30,||June 30,|
|General and administrative||$||2,574||$||4,678||$||4,661||$||6,901|
|Research and development||3,960||5,837||8,937||11,117|
|Total operating expenses||6,534||10,515||13,598||18,018|
|Loss from operations||(6,534||)||(10,515||)||(13,598||)||(18,018||)|
|Interest (expense) income||(144||)||13||(304||)||25|
|Loss before income taxes||(6,678||)||(10,502||)||(13,902||)||(17,998||)|
|Provision (benefit) for income taxes||—||—||—||—|
|Other comprehensive loss, net of tax||—||—||—||—|
|Net loss per share:|
|Basic and diluted||$||(0.47||)||$||(0.99||)||$||(1.04||)||$||(1.79||)|
|Number of shares used in per share calculations:|
|Basic and diluted||14,232,313||10,603,371||13,340,941||10,065,287|
|Gemphire Therapeutics Inc.|
|Balance Sheet Data|
|June 30,||December 31,|
|Cash and cash equivalents||$||28,039||$||18,473|
|Total current assets||28,798||19,009|
|Term loan (long-term portion)||7,540||8,683|
|Total stockholders’ equity||15,048||3,941|