-ZGN-1061 Phase 1 Data Support Continued
Development for Obese Patients with Type 2 Diabetes-
Zafgen, Inc. (Nasdaq:ZFGN), today announced its second quarter 2017
financial results.
“In the second quarter, we reached a critical
milestone in the development program for ZGN-1061, demonstrating
its favorable safety and pharmacokinetic profile with the results
of the Phase 1 clinical trial of our optimized MetAP2 inhibitor, as
well as early efficacy signals for ZGN-1061’s potential to improve
glycemic control and body weight,” said Thomas Hughes, Ph.D.,
President and Chief Executive Officer of Zafgen. “We also presented
two late-breaking abstracts at the American Diabetes Association's
(ADA) 77th Annual Scientific Sessions meeting in June, further
highlighting that ZGN-1061 treatment results in improvements across
multiple metabolic measures and demonstrates rapid drug absorption
and clearance, with no evidence of prothrombotic effects. We
believe ZGN-1061 offers a novel opportunity to address the unmet
medical need of patients who face the dual challenges of type 2
diabetes and obesity. We are on track to initiate a Phase 2
clinical trial studying the effects of ZGN-1061 on glycemic control
in patients with type 2 diabetes in the third quarter of this year.
In addition to our work in the clinic, we are ramping-up
manufacturing to provide bulk drug supply for our longer-term
studies.”
Recent Clinical Highlights
- In May, Zafgen reported positive topline data from both the
single ascending dose (SAD) and multiple ascending dose (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.
- In June, Zafgen presented additional data for ZGN-1061, in two
late-breaking posters at the ADA's 77th Annual Scientific Sessions.
A poster titled “Single and Multiple Dose Evaluation of a Novel
MetAP2 Inhibitor: Results of a Randomized, Double-Blind,
Placebo-Controlled Clinical Trial” detailed the full results from
the Phase 1 clinical trial of ZGN-1061, including new efficacy data
related to secondary endpoints. Specifically, ZGN-1061 produced
improvements in waist circumference relative to placebo and
resulted in a trend for reduced food intake relative to placebo.
The clinical trial also demonstrated trends for reductions in
LDL-cholesterol, and high-sensitivity C-reactive protein (hsCRP).
Notably, there were greater reductions in mean LDL-cholesterol and
hsCRP in ZGN-1061-treated subjects with abnormally elevated LDL or
hsCRP at baseline. Additionally, the clinical trial showed a trend
for reductions in leptin and increases in adiponectin with ZGN-1061
compared to placebo, reflective of favorable changes in adipose
function and signaling.In a second poster titled “The MetAP2
Inhibitor ZGN-1061 Improves Glycemia and has Weight Loss Efficacy
with an Improved Safety Profile in Preclinical Models,” Zafgen
presented preclinical data demonstrating that ZGN-1061 showed
similar beneficial effects on glycemic control, body weight, and
other metabolic endpoints, but with a greatly improved safety
profile in comparison to the Company’s prior development compound
beloranib. Data included results from a study comparing ZGN-1061,
beloranib and vehicle in a mouse model of obesity and insulin
resistance, as well as in vitro and in vivo data demonstrating the
impact of ZGN-1061 versus beloranib on multiple thrombotic
markers.
Based on the positive data from the Company’s
Phase 1 clinical trial and preclinical data supporting a
differentiated profile and improved safety margin versus first
generation MetAP2 inhibitors, Zafgen plans to initiate a Phase 2
clinical trial, ZAF-1061-201, in the third quarter of this year in
Australia and New Zealand. This clinical trial will be a three
month assessment, enrolling approximately 120 patients with type 2
diabetes who are overweight or obese. Patients will be randomized
3:1 and will be assigned to either placebo or one of three ZGN-1061
dosing arms, 0.05 mg, 0.3 mg and 0.9 mg, which will be administered
by subcutaneous injection every three days. The key objectives of
this clinical trial are to assess glycemic control, body weight, as
well as safety and tolerability, including coagulation related
measures.
Second Quarter 2017 Financial
Results
“Our priority continues to be utilizing our
current resources to advance ZGN-1061 through key value-creating
milestones,” stated Patricia Allen, Chief Financial Officer of
Zafgen. “With our focus on advancing ZGN-1061 while managing
our expenses and headcount, we now expect that our cash, cash
equivalents and marketable securities balance at the end of
calendar year 2017 will be greater than $70 million.”
Cash, Cash Equivalents and Marketable
SecuritiesAs of June 30, 2017, the Company had cash, cash
equivalents and marketable securities totaling $106.0 million.
Net LossThe Company reported a
net loss for the second quarter of 2017 of $13.3 million, or $0.49
per share, compared to a net loss of $15.0 million, or $0.55 per
share, for the second quarter of 2016.
The weighted average common shares (basic and
diluted) outstanding used to compute net loss per share were
27,407,408 for the second quarter of 2017, compared to 27,272,225
for the second quarter of 2016.
Research and Development
ExpensesResearch and development expenses for the second
quarter of 2017 were $10.5 million, compared to $10.2 million for
the second quarter of 2016. The slight increase in research and
development expenses for the second quarter of 2017 as compared to
the prior year period was primarily due to increased preclinical,
manufacturing and clinical trial costs related to ZGN-1061,
partially offset by a decrease in our beloranib program as well as
a decrease in personnel-related costs and consulting costs, as we
shifted focus to ZGN-1061 in July 2016.
General and Administrative
ExpensesGeneral and administrative expenses for the second
quarter of 2017 were $3.0 million, compared to $4.9 million for the
second quarter of 2016. The decrease in general and administrative
expenses for the second quarter of 2017 as compared to the prior
year period was primarily due to a decrease in professional fees
and non-cash stock-based compensation. For the second 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 now expects that its cash, cash equivalents and marketable
securities balance will be greater than $70 million as of December
31, 2017.
Conference Call Information
Zafgen will host an investor conference call
today, August 8, 2017 at 4:30 p.m., Eastern Time, to discuss the
Company's second quarter 2017 results as well as other
forward-looking information about Zafgen's business. Investors and
other interested parties may participate by dialing (844) 824-7428
in the United States or (973) 500-2177 outside the United States
and referencing conference ID number 51918952. The call will also
be webcast live on the Company's website at
https://zafgen.gcs-web.com/events-and-presentations. A replay of
this conference call will be available beginning at 7:30 p.m. ET on
August 8, 2017 through August 15, 2017 by dialing (855) 859-2056 in
the United States or (404) 537-3406 outside the United States. To
access the replay please provide Conference ID number 51918952.
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 preclinical 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 inhibitor 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 prothrombotic characteristics, compared
to first generation MetAP2 inhibitors, such as over beloranib, and
Zafgen's expectations with respect to the timing and success of its
preclinical 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 preclinical 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 preclinical studies and clinical trials of its product
candidates, Zafgen’s forecasted cash, cash equivalents and
marketable securities balance as of the end of its fiscal year,
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 Quarterly Report on Form 10-Q
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 June 30, |
|
Six Months Ended June 30, |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
10,528 |
|
|
|
10,163 |
|
|
|
20,205 |
|
|
|
22,660 |
|
General
and administrative |
|
|
3,008 |
|
|
|
4,899 |
|
|
|
6,596 |
|
|
|
10,259 |
|
Total
operating expenses |
|
|
13,536 |
|
|
|
15,062 |
|
|
|
26,801 |
|
|
|
32,919 |
|
Loss from
operations |
|
|
(13,536 |
) |
|
|
(15,062 |
) |
|
|
(26,801 |
) |
|
|
(32,919 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest
income |
|
|
247 |
|
|
|
225 |
|
|
|
474 |
|
|
|
434 |
|
Interest
expense |
|
|
(53 |
) |
|
|
(140 |
) |
|
|
(126 |
) |
|
|
(300 |
) |
Foreign
currency transaction gains (losses), net |
|
|
(5 |
) |
|
|
(51 |
) |
|
|
95 |
|
|
|
21 |
|
Total
other income (expense), net |
|
|
189 |
|
|
|
34 |
|
|
|
443 |
|
|
|
155 |
|
Net loss |
|
$ |
(13,347 |
) |
|
$ |
(15,028 |
) |
|
$ |
(26,358 |
) |
|
$ |
(32,764 |
) |
Net loss per share ,
basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.96 |
) |
|
$ |
(1.20 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
27,407,408 |
|
|
|
27,272,225 |
|
|
|
27,379,122 |
|
|
|
27,267,830 |
|
|
|
|
|
|
|
|
|
|
ZAFGEN, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2017 |
|
2016 |
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
31,726 |
|
|
$ |
32,352 |
|
Marketable securities |
|
|
74,266 |
|
|
|
96,842 |
|
Tax
incentive receivable |
|
|
368 |
|
|
|
347 |
|
Prepaid
expenses and other current assets |
|
|
1,605 |
|
|
|
1,358 |
|
Total
current assets |
|
|
107,965 |
|
|
|
130,899 |
|
Tax incentive
receivable |
|
|
234 |
|
|
|
- |
|
Property and equipment,
net |
|
|
588 |
|
|
|
661 |
|
Other assets |
|
|
58 |
|
|
|
61 |
|
Total
assets |
|
$ |
108,845 |
|
|
$ |
131,621 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
4,447 |
|
|
$ |
2,572 |
|
Accrued
expenses |
|
|
2,709 |
|
|
|
3,733 |
|
Notes
payable, current |
|
|
2,063 |
|
|
|
3,589 |
|
Total
current liabilities |
|
|
9,219 |
|
|
|
9,894 |
|
Total
liabilities |
|
|
9,219 |
|
|
|
9,894 |
|
Stockholders'
equity: |
|
|
|
|
Preferred
stock; $0.001 par value per share; 5,000,000 shares authorized as
of June 30,2017 and December 31, 2016; no shares issued and
outstanding as of June 30, 2017 andDecember 31, 2016 |
|
|
- |
|
|
|
- |
|
Common
stock, $0.001 par value per share; 115,000,000 shares authorized as
of June 30,2017 and December 31, 2016; 27,449,465 and 27,332,551
shares issued and outstandingas of June 30, 2017 and December 31,
2016, respectively |
|
|
27 |
|
|
|
27 |
|
Additional paid-in capital |
|
|
363,547 |
|
|
|
359,329 |
|
Accumulated deficit |
|
|
(263,907 |
) |
|
|
(237,549 |
) |
Accumulated other comprehensive loss |
|
|
(41 |
) |
|
|
(80 |
) |
Total
stockholders' equity |
|
|
99,626 |
|
|
|
121,727 |
|
Total
liabilities and stockholders' equity |
|
$ |
108,845 |
|
|
$ |
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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