Gemphire Announces Third Quarter 2016 Financial Results and Provides Corporate Update
"Since the successful closing of our initial public offering in August, we continued to make excellent progress in the development of gemcabene, our once-daily oral drug candidate for the treatment of multiple unmet needs in dyslipidemia and NASH,” said
THIRD QUARTER AND RECENT CORPORATE HIGHLIGHTS:
- Enrolled the first patient in the open-label COBALT-1 trial designed to determine the efficacy, safety and tolerability of gemcabene in patients with homozygous familial hypercholesterolemia (HoFH).
- Published Phase 2 data for gemcabene in the
Journal of Clinical Lipidology . The trial demonstrated that gemcabene, when added to stable statin therapy, resulted in a clinically meaningful reduction in LDL-C, hsCRP, and other key lipid parameters after eight weeks. - Appointed
Lee Golden , M.D. as Chief Medical Officer. Dr. Golden is an Interventional Cardiologist with extensive biotech and large cap pharma experience. - Sponsored the
FH Foundation to support research, advocacy, and education of all forms of familial hypercholesterolemia including HoFH and HeFH. - Announced that the European Patent Office granted European Patent No. 2658536, covering the use of gemcabene for decreasing the risk of developing pancreatitis in patients having a blood triglyceride level of 500 mg/dl or higher (SHTG), which adds to Gemphire’s corresponding patents in
the United States ,Australia , andMexico . - Furthered exploration of the utility of gemcabene in Nonalcoholic Steatohepatitis (NASH) and/or Nonalcoholic Fatty Liver Disease (NAFLD) given its mechanism of action of triglyceride lowering and reduction of inflammation which represent key hallmarks of NASH/NAFLD.
- Successfully completed an initial public offering of approximately 3 million shares of common stock, including the partial exercise of the underwriters’ over-allotment option, at
$10.00 per share, for proceeds of$26.2 million , net of underwriting discounts, commissions and offering-related transaction costs.
UPCOMING 2017 CLINICAL MILESTONES
- Interim data on COBALT-1 (HoFH) is planned for early 2017
- Topline data readout from COBALT-1 is currently anticipated in
June 2017 - Topline data readout from ROYAL-1 (HeFH/ASCVD) is currently anticipated in second half 2017
- Topline data readout from INDIGO-1 (SHTG) is currently anticipated in second half 2017
THIRD QUARTER FINANCIAL UPDATE
Cash and cash equivalents at
General and administrative expenses totaled
Research and development expenses were
Net loss attributable to common stockholders in the three and nine months ended
The Company expects to see increased operating expenses over the next several quarters, as compared to the respective prior year periods, resulting from increased personnel, consulting and professional costs in support of the clinical development of gemcabene. The Company believes that cash on hand at
CORPORATE UPDATE
In September, Gemphire announced publication of data from the previously completed Phase 2 clinical trial evaluating gemcabene in the
In October, Gemphire announced the appointment of
Also in October, the Company announced that the European Patent Office had granted European Patent No. 2658536 “Gemcabene and Derivatives for Treating Pancreatitis” covering the use of gemcabene for decreasing a patient’s risk of developing pancreatitis in patients having a blood triglyceride level of 500 mg/dl or higher. The patent is expected to provide coverage into 2031. Corresponding patents have also been granted in
ABOUT GEMPHIRE
Gemphire is 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, and NAFLD/NASH (nonalcoholic fatty liver disease). 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 and other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," 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 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 Quarterly Report on Form 10-Q for the quarterly period ended
Gemphire Therapeutics Inc. | |||||||||||
Balance Sheet Data | |||||||||||
(in thousands) | |||||||||||
September 30, | December 31, | ||||||||||
2016 | 2015 | ||||||||||
(unaudited) | |||||||||||
Cash and cash equivalents | $ | 28,369 | $ | 3,620 | |||||||
Total assets | 28,924 | 4,490 | |||||||||
Accounts payable and accrued liabilities | 1,936 | 2,148 | |||||||||
Convertible notes | — | 6,769 | |||||||||
Total liabilities | 1,936 | 8,917 | |||||||||
Series A convertible preferred stock | — | 7,953 | |||||||||
Common stock | 17 | 12 | |||||||||
Additional paid–in capital | 46,816 | — | |||||||||
Accumulated deficit | (19,845 | ) | (12,392 | ) | |||||||
Total stockholders’ equity (deficit) | 26,988 | (12,380 | ) |
Condensed Statements of Comprehensive Loss | |||||||||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||||||||
(unaudited) | |||||||||||||||||||||
For the Three Months Ended | For the Nine Months Ended | ||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||||||||
Operating expenses: | |||||||||||||||||||||
General and administrative | $ | 1,466 | $ | 997 | $ | 3,567 | $ | 2,130 | |||||||||||||
Research and development | 1,936 | 1,369 | 3,901 | 2,527 | |||||||||||||||||
Acquired in–process research and development | — | — | — | 908 | |||||||||||||||||
Total operating expenses | 3,402 | 2,366 | 7,468 | 5,565 | |||||||||||||||||
Loss from operations | (3,402 | ) | (2,366 | ) | (7,468 | ) | (5,565 | ) | |||||||||||||
Interest and other (expense) income | (476 | ) | (203 | ) | 96 | (894 | ) | ||||||||||||||
Net loss | $ | (3,878 | ) | $ | (2,569 | ) | $ | (7,372 | ) | $ | (6,459 | ) | |||||||||
Adjustment to redemption value on Series A convertible preferred stock | (67 | ) | (152 | ) | (366 | ) | (2,818 | ) | |||||||||||||
Net loss attributable to common stockholders | $ | (3,945 | ) | $ | (2,721 | ) | $ | (7,738 | ) | $ | (9,277 | ) | |||||||||
Net loss per share: | |||||||||||||||||||||
Basic and diluted | $ | (0.56 | ) | $ | (0.87 | ) | $ | (1.65 | ) | $ | (3.39 | ) | |||||||||
Number of shares used in per share calculations: | |||||||||||||||||||||
Basic and diluted | 6,983,667 | 3,124,804 | 4,703,774 | 2,732,876 |
CONTACT:Andrew McDonald , Ph.D.LifeSci Advisors, LLC (646) 597-6987Jeff Mathiesen , CFOGemphire Therapeutics (734)-245-1700