Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage
biopharmaceutical company focused on developing and commercializing
therapies for cardiometabolic disorders, including non-alcoholic
fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH)
and dyslipidemia, today announced financial results for the
first quarter ended March 31, 2018, and provided a corporate
update.
“Gemphire had a strong start to 2018 with continued progress
advancing gemcabene in the clinic,” said Steven Gullans, Ph.D., CEO
of Gemphire. “We launched a clinical program in NAFLD and NASH with
an initial focus on pediatric NAFLD and familial partial
lipodystrophy in adults. Our goal is that the two ongoing trials
will generate proof-of-concept data and prepare the way for
confirmatory trials in broader NASH adult and pediatric
populations. We believe that gemcabene’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 in these diseases, if approved.”
“We completed enrollment in the INDIGO-1 trial investigating
gemcabene in severe hypertriglyceridemia (SHTG) patients and we
look forward to announcing top line results in the near future,”
continued Dr. Gullans. “We believe that gemcabene has the
potential to become part of the standard of care for SHTG. With
approximately 3.5 million SHTG patients in the United
States alone that are at risk for developing acute
pancreatitis and organ failure, it represents one of the more
prevalent indications we are exploring. In these patients there is
an urgent need for fast and effective lowering of triglyceride
levels in order to prevent this progression to acute
pancreatitis.”
First Quarter 2018 and Recent Corporate
Highlights
- Completed patient enrollment in INDIGO-1 clinical trial
in severe hypertriglyceridemia (SHTG) patients.
- Phase 2b INDIGO-1 is a 12 week, multicenter, double-blind,
placebo-controlled, randomized trial investigating gemcabene in
patients with SHTG (TG ≥ 500mg/dL) with or without background
statin therapy.
- The primary endpoint is triglyceride (TG) reduction from
baseline after 12 weeks. The Company plans to report top-line
results in second quarter 2018.
- Initiated clinical program in pediatric nonalcoholic
fatty liver disease (NAFLD) and nonalcoholic
steatohepatitis (NASH) patients.
- GEM-IIT-601 Phase 2a trial is an open label, investigator
initiated, proof-of-concept (POC) trial with the expectation to
enroll approximately 40 adolescents (ages of 12 to 17) who are
diagnosed with NAFLD and abnormal liver function as assessed by
liver transaminases.
- The primary endpoint is a measure of the change in serum
alanine transaminase (ALT), an enzyme that serves as a biomarker of
liver function, from baseline to 12 weeks. Top line results
are expected in early 2019.
- Commenced additional Phase 2a study to investigate gemcabene in
familial partial lipodystrophy (FPL), a rare genetic disorder and
orphan disease which can lead to a variety of metabolic
abnormalities including NASH.
- Top line results are expected in the second half of
2018.
- Raised approximately $23 million in net
proceeds from a public offering of common stock.
- Appointed Steven Gullans, Ph.D., as President and Chief
Executive Officer.
- Dr. Gullans has almost 30 years of experience advising,
co-founding and investing in biotech companies across many fields
including cardiovascular disease. He had been Interim President and
Chief Executive Officer of Gemphire since May 2017.
Upcoming 2018 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 the 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 results.
- Advance two Phase 2a clinical trials in NAFLD/NASH, with
proof-of-concept data in the adult FPL trial reading out by the end
of 2018 and enrollment advancing in the pediatric NAFLD trial to
enable data readout in Q1 2019.
First Quarter 2018 Financial Update
General and administrative expenses for the first quarter ended
March 31, 2018 were $2.1 million compared to $2.2 million
for the first quarter ended March 31, 2017. Timing of costs related
to infrastructure supporting the ongoing clinical trials, and
public company requirements, focused primarily in personnel costs
and professional services, were the primary drivers of the activity
during both quarterly periods in 2018 and 2017.
Research and development expenses for the first quarter ended
March 31, 2018 were $5.0 million compared to $5.3 million for
the three months ended March 31, 2017. The decrease year over year
was primarily attributable to reduced clinical trial activities in
the first quarter of 2018 versus the comparable period in 2017.
Net loss attributable to common stockholders for the first
quarter ended March 31, 2018 was $7.2 million, or ($0.58) per
share, compared to $7.5 million, or ($0.79) per share, for the
first quarter ended March 31, 2017.
Cash used in operations in the first quarter ended March 31,
2018 was $7.2 million compared to $6.2
million for the first quarter of 2017. During the first
quarter of 2018, the Company raised approximately $23.1
million in net proceeds from a public offering of common
stock.
At March 31, 2018, the company had cash and cash equivalents of
approximately $34.5 million. Based on the Company’s current
operating plans, management believes the current cash on hand will
be sufficient to fund operations through mid-2019, including the
completion of the INDIGO-1 Phase 2b study in 2018, the initiation
of the Phase 3 program in dyslipidemia in the second half of 2018
and the completion of NASH/NAFLD Phase 2a studies in 2018 and the
first quarter of 2019.
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
(including the timing of the announcement of top-line results),
regulatory developments, submissions and meetings and future
expectations and plans and prospects for gemcabene and 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; timing of enrollment of patients in our
clinical trials; 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)
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
|
|
2018 |
|
2017 |
|
|
|
(Unaudited) |
|
(Unaudited) |
|
Operating
expenses: |
|
|
|
|
|
|
|
General and
administrative |
|
$ |
2,087 |
|
|
$ |
2,223 |
|
|
Research and
development |
|
|
4,977 |
|
|
|
5,280 |
|
|
Total operating
expenses |
|
|
7,064 |
|
|
|
7,503 |
|
|
Loss from
operations |
|
|
(7,064 |
) |
|
|
(7,503 |
) |
|
Interest (expense)
income |
|
|
(160 |
) |
|
|
12 |
|
|
Other expense |
|
|
— |
|
|
|
(5 |
) |
|
Loss before income
taxes |
|
|
(7,224 |
) |
|
|
(7,496 |
) |
|
Provision (benefit) for
income taxes |
|
|
— |
|
|
|
— |
|
|
Net loss |
|
|
(7,224 |
) |
|
|
(7,496 |
) |
|
Other comprehensive
loss, net of tax |
|
|
— |
|
|
|
— |
|
|
Comprehensive loss |
|
$ |
(7,224 |
) |
|
$ |
(7,496 |
) |
|
Net loss per
share: |
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.79 |
) |
|
Number of shares used
in per share calculations: |
|
|
|
|
|
|
|
Basic and diluted |
|
|
12,439,591 |
|
|
|
9,521,224 |
|
|
Gemphire Therapeutics
Inc.Balance Sheet Data(in
thousands)
|
|
March 31, |
|
December 31, |
|
|
|
2018 |
|
2017 |
|
|
|
(Unaudited) |
|
|
|
Cash and cash
equivalents |
|
$ |
34,461 |
|
|
$ |
18,473 |
|
|
Total assets |
|
$ |
34,837 |
|
|
$ |
19,017 |
|
|
Term loan |
|
$ |
10,115 |
|
|
$ |
10,038 |
|
|
Total liabilities |
|
$ |
14,020 |
|
|
$ |
15,076 |
|
|
Accumulated
deficit |
|
$ |
(67,698 |
) |
|
$ |
(60,474 |
) |
|
Total stockholders’
equity |
|
$ |
20,817 |
|
|
$ |
3,941 |
|
|
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