Gemphire Therapeutics Announces Workforce Reduction
September 24 2018 - 5:06PM
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), announces today that its
Board of Directors has approved a workforce reduction in order to
reduce costs and conserve cash resources. This decision was made in
light of the previously announced request by the Food and Drug
Administration (FDA) for additional pre-clinical data required in
order to schedule an End of Phase 2 meeting for gemcabene in the
Company’s target dyslipidemia indications.
The workforce reduction includes five employees, which represent
approximately 33% of the Company’s workforce, as of September 18,
2018. Two of the five employees include Jeffrey S. Mathiesen,
the Company’s Chief Financial Officer, and Lee Golden, the
Company’s Chief Medical Officer. Mr. Mathiesen and Dr. Golden
each depart in good standing with the Company. Mr. Mathiesen
has agreed to act as a consultant to Gemphire for a period of eight
months, to provide advice on certain financial and accounting
matters. Effective September 18, 2018, the Board designated Dr.
Steven Gullans, the Company’s President and Chief Executive
Officer, as the principal financial officer and principal
accounting officer of the Company.
"The workforce reduction is a necessary action to conserve
capital. We remain confident in the potential value of gemcabene as
a breakthrough therapy for dyslipidemia and are committed to
working with the FDA to complete the necessary steps to lift the
partial clinical hold,” said Steven Gullans, Ph.D., CEO of
Gemphire. “We appreciate the contributions and efforts of the
employees affected by this decision and thank them for their
dedicated service.”
As a result of the workforce reduction, the Company expects to
record severance related charges totaling approximately $1.4
million, which includes one-time cash severance payments of $0.5
million, a non-cash charge of approximately $0.9 million related to
the accelerated vesting of outstanding stock options for certain
affected employees and $26,300 for continued health insurance
coverage. The majority of the cash payments relating to
personnel-related restructuring charges will be paid during the
fourth quarter of 2018. The charges that the Company expects
to incur in connection with the workforce reduction are estimates
and subject to a number of assumptions, and actual results may
differ materially. The Company may incur additional costs not
currently contemplated due to events associated with or resulting
from the workforce reduction.
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 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
the estimated amount and timing of severance payments and charges
and the financial impact of the workforce reduction, 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: risks related to cost reduction efforts,
including that the Company’s workforce reduction costs may be
greater than anticipated and that the workforce reduction may have
an adverse impact on the Company’s drug development activities;
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.
Contact:Ashley RobinsonLifeSci Advisors,
LLC(617) 535-7742
Steve Gullans, CEOGemphire Therapeutics Inc.(508) 479
7086
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