-ZGN-1061 Phase 1 Data Support Continued
Development; On Track to Initiate Phase 2 Clinical Trial in
Patients with Type 2 Diabetes in Second Half of This Year-
Zafgen, Inc. (Nasdaq:ZFGN), today announced its first quarter 2017
financial results.
“We recently achieved an important milestone in
our clinical program for ZGN-1061, reporting positive topline data
from the Phase 1 clinical trial of ZGN-1061, a MetAP2 inhibitor
which has been optimized to improve glycemic control and body
weight, with a favorable safety profile,” said Thomas Hughes,
Ph.D., President and Chief Executive Officer of Zafgen. “The safety
data and the early efficacy signals support the further development
of this compound, and we plan to advance ZGN-1061 into a Phase 2
clinical trial in the second half of this year in patients with
type 2 diabetes who are overweight or obese.”
Recent Clinical Highlights
- Earlier this month, Zafgen reported positive topline data from
both the SAD and MAD portions of the Phase 1 clinical trial of
ZGN-1061, the Company’s second generation MetAP2 inhibitor.
ZGN-1061 was safe and well-tolerated, with no serious adverse
events (SAEs), and no severe adverse events (AEs). There were no
AEs leading to early withdrawal from the clinical trial.
- There was no prothrombotic effect observed with ZGN-1061. No
treatment emergent venous thromboembolisms (VTEs), no clinically
meaningful D-dimer elevations indicative of thrombosis and no
elevations in mean D-dimer levels were observed in the dosing
groups compared to baseline or placebo. There were no clinically
significant changes in coagulation laboratory parameters or other
key biomarkers of interest, including von Willebrand factor,
soluble thrombomodulin, and plasminogen activator inhibitor-1.
- On average, patients treated with ZGN-1061 for four weeks lost
weight relative to placebo-treated patients (-4.6 lbs, -2.2 lbs,
and -3.8 lbs for 0.2 mg, 0.6 mg, and 1.8 mg, respectively vs. -0.51
lbs for placebo), with trends for improvements observed in waist
circumference, food intake, low density lipoprotein-cholesterol,
C-reactive protein, adiponectin and leptin.
- Based on the positive data from the Phase 1 clinical trial,
together with non-clinical data supporting a differentiated profile
and improved safety margin versus first generation MetAP2
inhibitors, the Company plans to initiate a Phase 2 clinical trial
of ZGN-1061 in the second half of this year, in patients with type
2 diabetes who are overweight or obese.
First Quarter 2017 Financial
Results
“Our focused and disciplined investment in
ZGN-1061 will allow us to take this lead candidate through key
value-creating milestones with our current resources,” stated
Patricia Allen, Chief Financial Officer of Zafgen. “We
continue to expect our cash runway to extend through the end of
2018, by which time we expect to have data from the Phase 2
clinical trial for ZGN-1061.”
Cash, Cash Equivalents and Marketable
SecuritiesAs of March 31, 2017, the Company had cash, cash
equivalents and marketable securities totaling $116.9 million.
Net LossThe Company reported a
net loss for the first quarter of 2017 of $13.0 million, or $0.48
per share, compared to a net loss of $17.7 million, or $0.65 per
share, for the first quarter of 2016.
The weighted average common shares (basic and
diluted) outstanding used to compute net loss per share were
27,350,673 for the first quarter of 2017, compared to 27,263,435
for the first quarter of 2016.
Research and Development
ExpensesResearch and development expenses for the first
quarter of 2017 were $9.7 million, compared to $12.5 million for
the first quarter of 2016. The decrease in research and development
expenses for the first quarter of 2017 as compared to the prior
year period was primarily due to a decrease in our beloranib
program as well as a decrease in personnel related costs and
consulting costs, partially offset by increased pre-clinical,
manufacturing and clinical trial costs related to ZGN-1061 as we
shifted focus to ZGN-1061 in July 2016.
General and Administrative
ExpensesGeneral and administrative expenses for the first
quarter of 2017 were $3.6 million, compared to $5.4 million for the
first quarter of 2016. The decrease in general and administrative
expenses for the first quarter of 2017 as compared to the prior
year period was primarily due to a decrease in non-cash stock-based
compensation and professional fees. For the first quarter of 2017
there was also a decrease in personnel related costs as compared to
the prior year period primarily as a result of the reduction in
workforce during the third quarter of 2016.
2017 Financial GuidanceThe
Company expects that its cash, cash equivalents and marketable
securities balance will be greater than $65 million as of December
31, 2017.
About ZGN-1061
ZGN-1061 is a fumagillin-class, injectable small
molecule second generation MetAP2 inhibitor that was advanced into
development due to its unique properties that maximize impact on
metabolic parameters relevant to the treatment of type 2 diabetes
and other related metabolic disorders. In pre-clinical studies,
ZGN-1061 has demonstrated promising efficacy in animal models of
type 2 diabetes and obesity, with an improved pharmacokinetic
profile and safety margin relative to previous molecules in the
MetAP2 class. As demonstrated clinically for MetAP2 inhibitors,
ZGN-1061 is anticipated to improve glycemic control while also
helping to restore balance to fat metabolism, enabling calories to
once again be used as a productive energy source, leading to
improved metabolic control and long-term weight loss. Zafgen
recently completed its first Phase 1 clinical trial of ZGN-1061,
and is planning to advance the compound to Phase 2 clinical testing
in patients with type 2 diabetes who are overweight or
obese. Zafgen holds exclusive worldwide rights for the
development and commercialization of ZGN-1061.
About Zafgen
Zafgen (Nasdaq:ZFGN) is a biopharmaceutical
company dedicated to significantly improving the health and
well-being of patients affected by metabolic diseases including
type 2 diabetes and obesity. Zafgen is focused on developing novel
therapeutics that treat the underlying biological mechanisms of
metabolic diseases through the MetAP2 pathway. Zafgen has pioneered
the study of MetAP2 inhibitors in both common and rare forms of
obesity, and in patients affected by type 2 diabetes. Zafgen's lead
product candidate is ZGN-1061, which is a novel, first-in-class,
subcutaneous injection. Zafgen aspires to improve the lives of
patients through targeted treatments and has assembled a team
accomplished in bringing therapies to patients affected by
metabolic diseases.
Safe Harbor Statement
Various statements in this release concerning
Zafgen's future expectations, plans and prospects, including
without limitation, Zafgen's expectations regarding the use of
ZGN-1061 and other MetAP2 inhibitors as treatments for metabolic
diseases including type 2 diabetes and obesity, ZGN-1061’s improved
safety margin, including as it relates to pro-thrombotic
characteristics, compared to first generation MetAP2 inhibitors,
such as over beloranib, and Zafgen's expectations with respect to
the timing and success of its pre-clinical studies and clinical
trials of ZGN-1061 and its other product candidates, and Zafgen's
expected cash, cash equivalents and marketable securities balance
as of December 31, 2017, may constitute forward-looking
statements for the purposes of the safe harbor provisions under 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 ZGN-1061 and its
other product candidates from first generation MetAP2 inhibitors,
such as beloranib, the pre-clinical 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
pre-clinical studies and clinical trials of its product candidates,
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
dependence on third parties for development, manufacture,
marketing, sales and distribution of product candidates, the
outcome of litigation, 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. 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.
ZAFGEN,
INC. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(In thousands, except share and per share
data) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
Revenue |
|
$ |
- |
|
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
Research
and development |
|
|
9,677 |
|
|
|
12,497 |
|
|
General
and administrative |
|
|
3,588 |
|
|
|
5,360 |
|
|
Total operating expenses |
|
|
13,265 |
|
|
|
17,857 |
|
|
Loss from
operations |
|
|
(13,265 |
) |
|
|
(17,857 |
) |
|
Other
income (expense): |
|
|
|
|
|
Interest
income |
|
|
227 |
|
|
|
209 |
|
|
Interest
expense |
|
|
(73 |
) |
|
|
(160 |
) |
|
Foreign
currency transaction gains (losses), net |
|
|
100 |
|
|
|
72 |
|
|
Total other income (expense), net |
|
|
254 |
|
|
|
121 |
|
|
Net
loss |
|
$ |
(13,011 |
) |
|
$ |
(17,736 |
) |
|
Net loss
per share , basic and diluted |
|
$ |
(0.48 |
) |
|
$ |
(0.65 |
) |
|
Weighted
average common shares outstanding, basic and diluted |
|
|
27,350,673 |
|
|
|
27,263,435 |
|
|
|
ZAFGEN,
INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
March 31, |
|
December 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
28,632 |
|
|
$ |
32,352 |
|
Marketable securities |
|
|
88,304 |
|
|
|
96,842 |
|
Tax
incentive receivable |
|
|
368 |
|
|
|
347 |
|
Prepaid
expenses and other current assets |
|
|
1,378 |
|
|
|
1,358 |
|
Total current assets |
|
|
118,682 |
|
|
|
130,899 |
|
Property and equipment,
net |
|
|
630 |
|
|
|
661 |
|
Other assets |
|
|
59 |
|
|
|
61 |
|
Total assets |
|
$ |
119,371 |
|
|
$ |
131,621 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
1,910 |
|
|
$ |
2,572 |
|
Accrued
expenses |
|
|
3,850 |
|
|
|
3,733 |
|
Notes
payable, current |
|
|
2,837 |
|
|
|
3,589 |
|
Total current liabilities |
|
|
8,597 |
|
|
|
9,894 |
|
Total liabilities |
|
|
8,597 |
|
|
|
9,894 |
|
Stockholders'
equity: |
|
|
|
|
Preferred
stock; $0.001 par value per share; 5,000,000 shares authorized as
of March 31, 2017 and December 31, 2016; no shares issued and
outstanding as of March 31, 2017 and December 31, 2016 |
|
|
- |
|
|
|
- |
|
Common
stock, $0.001 par value per share; 115,000,000 shares authorized as
of March 31, 2017 and December 31, 2016; 27,350,723 and 27,332,551
shares issued and outstanding as of March 31, 2017 and December 31,
2016, respectively |
|
|
27 |
|
|
|
27 |
|
Additional paid-in capital |
|
|
361,370 |
|
|
|
359,329 |
|
Accumulated deficit |
|
|
(250,560 |
) |
|
|
(237,549 |
) |
Accumulated other comprehensive loss |
|
|
(63 |
) |
|
|
(80 |
) |
Total stockholders' equity |
|
|
110,774 |
|
|
|
121,727 |
|
Total liabilities and stockholders' equity |
|
$ |
119,371 |
|
|
$ |
131,621 |
|
|
|
|
|
|
This selected financial information should be read in
conjunction with the consolidated financial statements and notes
thereto included in the Company's Annual Report on Form 10-K which
includes the Company’s audited consolidated financial statements
for the year ended December 31, 2016.
Media/Investor Relations Contact:
Zafgen, Inc.
Patricia Allen
Chief Financial Officer
617-648-9792
Argot Partners
Investor Relations
Laura Perry
212-600-1902
laura@argotpartners.com
Spectrum Science
Media Relations
Michelle Strier
202-587-2582
mstrier@spectrumscience.com
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