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LIVONIA, Mich., March 15, 2019 (GLOBE NEWSWIRE) -- Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease, focused on orphan indications, as well as nonalcoholic fatty liver disease (NAFLD/NASH), today announced its financial results for the quarter and fiscal year ended December 31, 2018, and provided a corporate update.
“2018 was a year of progress for Gemphire with our Phase 2 INDIGO-1 trial investigating gemcabene in severe hypertriglyceridemia (SHTG) successfully meeting its primary endpoint,” said Steven Gullans, Ph.D., CEO of Gemphire. “In addition, patient enrollment was completed in an investigator-initiated Phase 2 study in familial partial lipodystrophy (FPL). On the other hand, the FDA requested that we provide additional information regarding preclinical toxicology before it will consider lifting our clinical hold and scheduling an End of Phase 2 (EOP2) meeting. We are moving propitiously to achieve this milestone and move into Phase 3.”
“In August, we received unexpected news when the pediatric non-alcoholic fatty liver disease (NAFLD) study was halted early by the Data Safety Monitoring Board (DSMB) due to unanticipated problems,” added Gullans. “While there were no serious adverse events (SAEs), the first three patients experienced increased circulating liver enzyme levels and increased liver fat content. Unlike prior studies of gemcabene in adults, the pediatric patients gained weight and did not experience a decrease in serum triglycerides (TGs). Moreover patients were poorly compliant in taking the drug as assessed by tablet counts and blood drug levels. Being cautious with regard to the patients, we fully supported the decision to discontinue the trial, and we look forward to seeing how and whether, we can further resolve these findings.”
Fourth Quarter and Recent Corporate Highlights
Fourth Quarter and Fiscal 2018 Financial Update
General and administrative expense for the fourth quarter and fiscal year ended December 31, 2018 was $1.5 million and $8.5 million, respectively, compared to $1.5 million and $10.4 million for the fourth quarter and fiscal year ended December 31, 2017, respectively. The decrease for the year was primarily attributable to lower separation costs in the 2018 period when compared to 2017.
Research and development expense for the fourth quarter and fiscal year ended December 31, 2018 was $1.8 million and $14.3 million, respectively, compared to $5.1 million and $22.7 million for the fourth quarter and fiscal year ended December 31, 2017, respectively. The decrease for the year was primarily attributable to reduced clinical trial activities in 2018 compared to 2017, partially offset by separation costs recorded as research and development expenses in connection with the September 2018 reduction-in-workforce.
Net loss for the fourth quarter and fiscal year ended December 31, 2018 was $3.7 million, or ($0.26) per share, and $23.6 million, or ($1.71) per share, respectively, compared to $6.7 million, or ($0.63) per share, and $33.4 million, or ($3.23) per share, for the fourth quarter and fiscal year ended December 31, 2017, respectively.
At December 31, 2018, the company had cash and cash equivalents of approximately $19 million. Based on the Company’s current operating plans, management believes the current cash on hand (net of our SVB Term Loan prepayment in January 2019) will be sufficient to fund operations into the third quarter of 2019. Management believes we will need to raise additional capital to continue to fund the further development of gemcabene and our operations thereafter, including submission of the additional information requested by the FDA to lift the partial clinical hold.
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, hypertriglyceridemia and fatty liver disease, including FH, SHTG, NASH/NAFLD, and ASCVD. 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, such as statements about the plan of the Board of Directors to conduct a review of strategic alternatives to maximize stockholder value, the clinical development of Gemphire’s product candidate, gemcabene, expectations regarding clinical trials, expected timing of top-line results of such trials, timing and expectations for pre-clinical studies, regulatory submissions and meetings, future expectations and plans and prospects for gemcabene, and other statements containing the words “believes,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “promising,” “targets,” “may,” “potential,” “will,” “would,” “could,” “should,” “continue,” “scheduled,” “goal” 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 ability of the Company to successfully and timely negotiate and consummate a possible transaction on terms that are favorable to the Company; whether desirable products and combinations can be identified; risks related to cost reduction efforts; Gemphire’s ability to analyze the results and understand the reasons for the unexpected events in the Phase 2a pediatric NAFLD trial; that MRI-PDFF scans or other follow-up tests of patients show similar increases in liver fat content or other undesirable side effects; uncertainties inherent in the clinical drug development process and the regulatory approval process, including the risk that gemcabene may have 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 most recent annual report, subsequent quarterly reports 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
Gemphire Therapeutics Inc.
Condensed Statements of Comprehensive Loss
(in thousands, except per share amounts)
|Year Ended||Three Months Ended|
|December 31,||December 31,|
|General and administrative||$||8.493||$||10,438||$||1,468||$||1,487|
|Research and development||14,312||22,686||1,833||5,080|
|Total operating expenses||22,805||33,124||3,301||6,567|
|Loss from operations||(22,805||)||(33,124||)||(3,301||)||(6,567||)|
|Other comprehensive loss, net of tax||—||—||—||—|
|Net loss per share:|
|Basic and diluted||$||(1.71||)||$||(3.23||)||$||(0.26||)||$||(0.63||)|
|Number of shares used in per share calculations:|
|Basic and diluted||13,805,552||10,349,136||14,265,411||10,633,042|
Gemphire Therapeutics Inc.
Balance Sheet Data
|Cash and cash equivalents||$||18,954||$||18,473|
|Term loan (short-term portion)||9,437||1,355|
|Term loan (long-term portion)||—||8,683|
|Total stockholders’ equity||7,774||3,941|