Zafgen to Explore Strategic Alternatives
September 05 2019 - 7:00AM
Zafgen, Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical
company leveraging its proprietary knowledge of MetAP2 systems
biology to develop novel therapies for patients affected by a range
of metabolic diseases, today announced plans to explore strategic
options to maximize shareholder value. Potential strategic
alternatives that may be evaluated include, but are not limited to,
an acquisition, merger, business combination, in-licensing, or
other strategic transaction involving the Company or its assets.
“Given the alignment and clarity of our recent work with the
FDA, and the preliminary results from our ongoing
nonclinical study to translate in vitro differentiation
results into an in vivo model system, we
believe there is low probability of resolving the clinical
hold in the near-term. Because of this, Zafgen has determined that
it is in the best interest of shareholders to expand our internal
corporate development efforts and formally evaluate strategic
alternatives,” said Jeffrey Hatfield, Chief Executive Officer. “A
transaction committee has been formed within the Board of
Directors, and we will update investors as appropriate.”
In July 2019, Zafgen announced that it had reached agreement
with the U.S. Food and Drug Administration (FDA) on an in vivo
animal study design and protocol to establish relevant safety
margins for ZGN-1061, its investigational MetAP2 inhibitor in
development. The study is designed to translate the data from
Zafgen’s newly developed in vitro assays of human endothelial cells
and assessment of tissue factor expression with endothelial cells,
along with other supportive assays. Based on preliminary results
from this study reviewed this week, Zafgen does not presently
expect the data to warrant resolution of the clinical hold for
ZGN-1061.
Based
on previously announced and recently implemented plans to reduce
operating expenses and prioritize key resources, Zafgen expects its
projected cash runway to last greater than two years, given its
current operating plan.
The Company has retained MTS Health Partners L.P. as its
exclusive advisor to assist the Company in exploring alternatives.
There can be no assurance that the exploration of strategic
alternatives will result in any transaction being entered into or
consummated. The Company has not set a timetable for completion of
this review process and the Company does not intend to comment
further unless or until the Board of Directors has approved a
definitive course of action, the review process is concluded, or it
is determined that other disclosure is appropriate.
About ZafgenZafgen (Nasdaq:ZFGN) is a
clinical-stage biopharmaceutical company leveraging its proprietary
MetAP2 biology platform to develop novel therapies for patients
affected by complex metabolic diseases. Zafgen has pioneered the
study of MetAP2 inhibitors in both common and rare metabolic
disorders. Learn more at www.zafgen.com.
Safe Harbor Statement Various statements
in this release concerning Zafgen's future expectations,
plans and prospects, including without
limitation, Zafgen's expectations regarding the
development and use of ZGN-1061 as a treatment for metabolic
diseases, nonclinical or clinical options to resolve the clinical
hold concerning ZGN-1061, Zafgen's expectations with respect
to the timing and success of its nonclinical studies and clinical
trials of ZGN-1061 and its other product candidates, Zafgen’s plans
to explore strategic alternatives, and Zafgen’s expectations
regarding the length of its cash runway, may constitute
forward-looking statements for the purposes of the safe harbor
provisions of The Private Securities Litigation Reform Act of 1995
and other federal securities laws. Forward-looking statements can
be identified by terminology such as "anticipate," "believe,"
"could," "could increase the likelihood," "estimate," "expect,"
"intend," "is planned," "may," "should," "will," "will enable,"
"would be expected," "look forward," "may provide," "would" or
similar terms, variations of such terms or the negative of those
terms. Actual results may differ materially from those indicated by
these forward-looking statements as a result of various important
factors, including, without limitation, Zafgen's ability
to successfully demonstrate the efficacy and safety of ZGN-1061 and
its other product candidates and to differentiate them from first
generation MetAP2 inhibitors, such as beloranib, the nonclinical
and clinical results for ZGN-1061 and its other product candidates,
which may not support further development and marketing approval,
actions of regulatory agencies, which may affect the initiation,
timing and progress of nonclinical studies and clinical trials of
its product candidates, Zafgen's ability to execute the in
vivo animal study designed in alignment with the FDA, establish
acceptable safety margins on ZGN-1061 based on the results of such
study and resolve the clinical hold on ZGN-1061 based on the
results of such study, Zafgen’s ability to overcome the full
clinical hold placed on ZGN-1061 by the FDA and obtain regulatory
approval, Zafgen’s ability to explore strategic alternatives and
enter into and consummate a transaction as a result of such
process, Zafgen's ability to obtain, maintain and protect its
intellectual property, Zafgen's ability to enforce its
patents against infringers and defend its patent portfolio against
challenges from third parties, competition from others developing
products for similar uses, Zafgen’s ability to manage operating
expenses, Zafgen's ability to obtain additional funding
to support its business activities and establish and maintain
strategic business alliances and new business initiatives when
needed, Zafgen’s ability to attract and retain personnel,
Zafgen's dependence on third parties for development,
manufacture, marketing, sales and distribution of product
candidates, and unexpected expenditures, as well as those risks
more fully discussed in the section entitled "Risk Factors"
in Zafgen's most recent Annual Report on Form 10-K filed
with the Securities and Exchange Commission, as well as
discussions of potential risks, uncertainties, and other important
factors in Zafgen's subsequent filings with
the Securities and Exchange Commission, including without
limitation Zafgen’s Quarterly Reports on Form 10-Q. In addition,
any forward-looking statements represent Zafgen's views
only as of today and should not be relied upon as representing its
views as of any subsequent date. Zafgen explicitly disclaims
any obligation to update any forward-looking statements, whether as
a result of new information, future events or otherwise.
Media/Investor Relations Contacts:Zafgen, Inc.
Patricia Allen Chief Financial Officer 617-648-9792
MediaKrystle GibbsTen Bridge Communications
krystle@tenbridgecommunications.com 508-479-6358
InvestorsJohn
WoolfordWestwickejohn.woolford@westwicke.com443-213-0506
Zafgen (NASDAQ:ZFGN)
Historical Stock Chart
From Nov 2024 to Dec 2024
Zafgen (NASDAQ:ZFGN)
Historical Stock Chart
From Dec 2023 to Dec 2024