Conference Call & Live Webcast Today at
4:30pm Eastern Time
Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage
biopharmaceutical company focused on developing and commercializing
therapies for cardiometabolic disorders, including dyslipidemia,
non-alcoholic fatty liver disease (NAFLD) and nonalcoholic
steatohepatitis (NASH), today announced its financial results
for the quarter and fiscal year ended December 31, 2017, and
provided a corporate update.
“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
- Completed patient enrollment in Phase 2b INDIGO-1 trial
investigating gemcabene in severe hypertriglyceridemia (SHTG)
patients.
- INDIGO-1 is a 12 week, multicenter, double-blind,
placebo-controlled, randomized trial in patients with SHTG (TG ≥
500mg/dL) with or without background statin therapy.
- Patients are enrolled into one of three arms: gemcabene 300 mg,
gemcabene 600 mg or placebo once daily.
- The primary endpoint is triglyceride (TG) reduction from
baseline after 12 weeks.
- Company remains on track to report top-line results from the
study in the second quarter of 2018.
- Launched a Clinical Program to Develop Gemcabene as a
Treatment for NASH/NAFLD.
- Initiated a Phase 2a proof-of-concept (POC) clinical trial
investigating gemcabene as a treatment for pediatric NAFLD.
Pediatric NAFLD/NASH is a large and untreated market and provides
an opportunity to advance gemcabene in an underserved area with
millions of affected patients.
- This open label pediatric trial is expected to enroll
approximately 40 adolescent children between the ages of 12 and 17
who are diagnosed with NAFLD and abnormal liver function as
assessed by liver transaminases. Top line results are
expected in early 2019.
- As part of its NASH program, Gemphire also initiated a Phase 2a
clinical trial investigating gemcabene in Familial Partial
Lipodystrophy (FPL). FPL is a rare genetic disorder and
orphan disease which can lead to a variety of metabolic
abnormalities including NASH.
- The trial is designed to assess the efficacy and safety of two
dosing regimens of gemcabene in up to eight FPL patients with
elevated TGs and NAFLD. Top line results are expected in the
second half of 2018.
- The trials in pediatric NAFLD and FPL have been designed to
pave the way for confirmatory trials in a broader NASH adult and
pediatric population.
- Presented poster at The Liver Meeting®, the annual
meeting of the Association for the Study of Liver Diseases
(AASLD).
- Data from a preclinical study support clinical evaluation of
gemcabene as a potential treatment for NAFLD/NASH.
- Presented final results for ROYAL-1 clinical data in
hypercholesterolemic patients at the American Heart Association
(AHA) scientific sessions.
- Gemcabene met the primary endpoint and demonstrated a
statistically significant lowering in LDL-C when used as an add-on
for patients on maximally tolerated doses of statins.
- Gemcabene was well tolerated with no evidence of drug-drug
interactions (DDIs), liver toxicity, or muscle toxicity as an
add-on to the highest doses of statins.
- Greater efficacy was observed in a cardiometabolic population,
patients with mixed dyslipidemia who have a particularly high
atherogenic particle burden. In the mixed dyslipidemia group
of patients, gemcabene 600 mg demonstrated a placebo adjusted LDL-C
reduction of 23% (p < 0.05) on top of the highest doses of
statins.
- Consistent with gemcabene’s mechanism of action, the sub-set of
patients who had mixed dyslipidemia showed placebo adjusted
reductions in non-HDL-C of 19%, ApoB of 26%, ApoE of 34% and
triglycerides (TGs) of 33%.
- Gemcabene treatment was associated with a significant median
reduction in high-sensitivity C-reactive protein (hsCRP) of 40%,
compared to 6% for those treated with placebo. hsCRP is a biomarker
for inflammation and there is growing acceptance that reducing
hsCRP is associated with reductions in major adverse cardiovascular
events (MACE).
- Raised approximately $23 million in net proceeds from a
public offering of common stock in the first quarter of
2018.
Upcoming 2018 Clinical Milestones
- Top-line results from the INDIGO-1 Phase 2b trial in SHTG are
targeted for the second quarter of 2018 following completion of
enrollment in the first quarter of 2018.
- Reaching agreement with FDA on the design of a Phase 3 program
in familial hypercholesterolemia (FH) to enable initiation of Phase
3 study of gemcabene in FH by the end of 2018. In addition we plan
to resolve our partial clinical hold with the FDA by completing and
submitting our two-year rodent carcinogenicity study.
- Advance two Phase 2a clinical trials in NAFLD/NASH with
Proof-of-Concept data in adult FLP reading out by the end of 2018,
and enrollment advancing in pediatric NAFLD to enable data readout
in Q1 2019.
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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