Recently announced positive results for second
cohort of Phase 2 clinical trial of ZGN-1061
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 reported its fourth quarter and full
year 2018 operating and financial results along with key program
updates for ZGN-1061 and ZGN-1258 and other business updates.
Program Updates
ZGN-1061In January 2019, Zafgen announced positive data for the
second cohort of its Phase 2 clinical trial of ZGN-1061 in patients
with type 2 diabetes. The clinical trial met all of its primary
objectives at the 1.8 mg dose, which included glycemic control, or
change in A1C, and safety and tolerability. Treatment with ZGN-1061
showed a statistically significant reduction in A1C for 1.8 mg
versus placebo, with a 1.1% reduction. A1C levels continued to
decline with no waning of effect for both doses through Week 12.
Progressive and notable reduction in body weight was observed at
the 1.8 mg dose with no evidence of waning effect. The data also
showed a favorable safety and tolerability profile for ZGN-1061
through 12 weeks of treatment, with no treatment-related serious
adverse events and no cardiovascular (CV) safety signals
observed.
Zafgen has made important progress in preparation for a Type A
meeting to address the concerns raised by the U.S. Food and Drug
Administration (FDA) with the clinical hold for ZGN-1061. The
Company plans to provide key new data, including: newly developed
in vitro assays of human plasma coagulation using endothelial cells
and assessment of tissue factor expression with endothelial cells,
and other supportive new assays, all of which Zafgen believes
continue to substantially differentiate ZGN-1061 from the Company’s
prior compound; and the efficacy data and the full safety data from
the second cohort of the Phase 2 clinical trial. An update is
anticipated in the second quarter of 2019.
ZGN-1258Zafgen is also announcing its decision to suspend plans
to file an investigational new drug (IND) application for ZGN-1258,
the Company’s candidate for rare metabolic disorders including
Prader-Willi syndrome (PWS), based on a recent, unexpected finding
in muscle tissue in four- and six-month long-term rodent toxicology
studies. Nonclinical data showed degeneration and other anomalies
in rat muscle tissue to different degrees in both vehicle and dose
arms of the studies. The effects were absent from other animal
species in long term models, and importantly, this finding has not
been observed in any of the Company’s other MetAP2 inhibitors or
clinical trials and appears to be specific to ZGN-1258. Zafgen
will provide an update on plans for ZGN-1258 at a later time, if
warranted, following further evaluation.
“Our mission at Zafgen to develop safe, effective and
potentially transformative treatment options to patients who could
benefit, centers on applying the highest scientific rigor to our
development efforts and letting the data lead us. For ZGN-1061, we
are very pleased with the strong data that continue to support the
profile of this novel MetAP2 inhibitor for patients with type 2
diabetes. I am proud of the team’s diligent, solution-oriented
approach to addressing the FDA’s comments on the ZGN-1061 IND
application, and we look forward to presenting these new, more
sophisticated assays and full safety results as the basis of what
we hope is a productive and collaborative dialogue to advance the
ZGN-1061 program,” said Jeffrey Hatfield, Chief Executive Officer,
Zafgen.
Mr. Hatfield continued, “We are, of course, extremely
disappointed to suspend our IND filing plans for ZGN-1258. We
proactively initiated long-term toxicology studies prior to filing
an IND, and that decision now allows us to take the necessary steps
to assess the unexpected effects we observed. The entire team at
Zafgen is driven by a deep commitment to people with PWS and their
families, and we’ll continue to evaluate ZGN-1258, as well as
explore other potential options within our portfolio of MetAP2
inhibitors, to address the devastating hyperphagia experienced by
those with PWS. Zafgen has a strong cash position through 2020 to
execute on our strategic objectives.”
PATH for PWS, Zafgen’s natural history study conducted in
collaboration with the Foundation for Prader-Willi Research (FPWR),
is independent of any specific development program and continues
enrollment, with more than 400 of the 500-participant goal now
enrolled. The data from this study are intended to inform the
development and clinical trial design of potential new
treatments.
Corporate Updates
Last week, Zafgen appointed a key executive to its leadership
team, Priya Singhal, M.D., M.P.H., as Head of Research and
Development, who brings nearly a decade of senior drug development
experience in R&D strategy, drug safety and benefit-risk
management. Dr. Singhal is responsible for leading and overseeing
research, clinical and manufacturing strategy and implementation
across the Company’s portfolio of investigational MetAP2
inhibitors.
Zafgen is also announcing that Dennis Kim, M.D. has resigned
from his position as the Company’s Chief Medical Officer (CMO) to
serve as a senior consultant in a CMO capacity for multiple
biotechnology companies. Dr. Kim will support a transition process
over the next several weeks.
“Priya brings an invaluable depth of R&D expertise and
leadership to Zafgen and is ideally suited to drive efforts across
all our key areas of focus. We are so thrilled that she has joined
the Zafgen team,” said Mr. Hatfield. “We also want to thank Dennis
for his many contributions to Zafgen and his commitment to the
patients and families that are at the heart of our work. We wish
him all the best in this new chapter of his career.”
Fourth Quarter and Full Year 2018 Financial
Results
Cash, Cash Equivalents and Marketable
Securities
As of December 31, 2018, the Company had cash, cash equivalents
and marketable securities totaling $118.1 million.
Net Loss
The Company reported a net loss for the fourth quarter of 2018
of $14.6 million, or $0.39 per share, compared to a net loss of
$13.1 million, or $0.48 per share, for the fourth quarter of 2017.
For the full year 2018, the Company reported a net loss of $61.4
million, or $1.90 per share, compared to $52.0 million, or $1.90
per share, for the full year 2017.
The weighted average common shares (basic and diluted)
outstanding used to compute net loss per share were 37,036,065 for
the fourth quarter of 2018 compared to 27,489,397 for the same
quarter of 2017. For the full year 2018, weighted average common
shares (basic and diluted) outstanding used to compute net loss per
share were 32,228,721 compared to 27,433,239 for the full year
2017.
Research and Development Expenses
Research and development expenses for the fourth quarter of 2018
were $11.5 million compared to $10.9 million for the fourth quarter
of 2017. The increase in research and development expenses compared
to the prior year period was primarily due to increased costs
related to the ZGN-1258 program as nonclinical studies progressed
during the quarter. These increases in research and development
costs were partially offset by a decrease in non-cash stock-based
compensation expense and nonclinical and manufacturing costs
associated with our ZGN-1061 program in the fourth quarter of 2018
as compared to the fourth quarter of 2017.
For the full year 2018, research and development expenses were
$47.9 million, compared to $40.8 million for the full year 2017.
The increase in research and development expenses for the full year
period was primarily due to increased costs related to the ZGN-1258
program as nonclinical studies progressed during the year. There
were also increases in personnel related costs and non-cash
stock-based compensation expense for the full year 2018 as compared
to the full year 2017. The increase was partially offset by a
decrease in nonclinical and manufacturing costs associated with our
ZGN-1061 program during the full year 2018.
General and Administrative Expenses
General and administrative expenses for the fourth quarter of
2018 were $3.2 million, compared to $2.4 million for the fourth
quarter of 2017. The increase in general and administrative
expenses as compared to the prior year period was primarily due to
an increase in personnel related costs and non-cash stock-based
compensation expense.
For the full year 2018, general and administrative expenses were
$13.2 million, compared to $12.2 million for the full year 2017.
The increase in general and administrative expenses for the full
year 2018 as compared to the prior year period was primarily due to
an increase in personnel related costs and public company
costs.
Conference Call Information
Zafgen will host an investor conference call today, March 11,
2019, at 5:00 p.m., Eastern Time, to discuss the Company's fourth
quarter and full year 2018 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 2067548. 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 8:00 p.m. ET on
March 11, 2019 through March 18, 2019 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 2067548.
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 and is currently researching or advancing
programs for type 2 diabetes, Prader-Willi syndrome and liver
diseases. 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 use of
ZGN-1258, ZGN-1061, ZGN-1345 and other second-generation MetAP2
inhibitors as treatments for metabolic diseases including
Prader-Willi syndrome, type 2 diabetes, liver diseases and obesity
and Zafgen's expectations with respect to the timing and
success of its ability to collect and analyze PATH for PWS data for
development and clinical trial design and with respect to its
nonclinical studies and clinical trials of ZGN-1258, ZGN-1061,
ZGN-1345 and its other product candidates, Zafgen’s expected cash,
cash equivalents and marketable securities balance as of December
31, 2018, 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-1258, ZGN-1061, ZGN-1345 and its
product candidates and to differentiate them from first generation
MetAP2 inhibitors, such as beloranib, the nonclinical and clinical
results for ZGN-1258, ZGN-1061, ZGN-1345 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
successfully engage with the FDA concerning the clinical hold on a
clinical trial of ZGN-1061 and to design and conduct a nonclinical
study or clinical trial demonstrating sufficient data to exclude
cardiovascular risk to an acceptable degree, Zafgen’s ability to
overcome the full clinical hold place on ZGN-1061 by the FDA and
obtain regulatory approval, Zafgen’s ability to continue to
evaluate ZGN-1258 and to advance the program in nonclinical and
clinical development, 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, 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,
INC. |
CONSOLIDATED STATEMENTS OF
OPERATIONS |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
2018 |
|
|
|
2017 |
|
|
|
2016 |
|
Revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
|
|
Research
and development |
|
47,929 |
|
|
|
40,839 |
|
|
|
39,936 |
|
General
and administrative |
|
13,193 |
|
|
|
12,160 |
|
|
|
18,289 |
|
Total
operating expenses |
|
61,122 |
|
|
|
52,999 |
|
|
|
58,225 |
|
Loss from
operations |
|
(61,122 |
) |
|
|
(52,999 |
) |
|
|
(58,225 |
) |
Other income
(expense): |
|
|
|
|
|
Interest
income |
|
1,889 |
|
|
|
996 |
|
|
|
894 |
|
Interest
expense |
|
(1,898 |
) |
|
|
(165 |
) |
|
|
(529 |
) |
Foreign
currency transaction (losses) gains, net |
|
(237 |
) |
|
|
140 |
|
|
|
(18 |
) |
Total
other (expense) income, net |
|
(246 |
) |
|
|
971 |
|
|
|
347 |
|
Net loss |
$ |
(61,368 |
) |
|
$ |
(52,028 |
) |
|
$ |
(57,878 |
) |
Net loss per share,
basic and diluted |
$ |
(1.90 |
) |
|
$ |
(1.90 |
) |
|
$ |
(2.12 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
32,228,721 |
|
|
|
27,433,239 |
|
|
|
27,297,934 |
|
|
|
|
|
|
|
|
|
|
|
|
|
ZAFGEN,
INC. |
CONSOLIDATED STATEMENTS OF
OPERATIONS |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
Three Months Ended December 31, |
|
|
2018 |
|
|
|
2017 |
|
Revenue |
$ |
- |
|
|
$ |
- |
|
Operating
expenses: |
|
|
|
Research
and development |
|
11,457 |
|
|
|
10,911 |
|
General
and administrative |
|
3,234 |
|
|
|
2,447 |
|
Total
operating expenses |
|
14,691 |
|
|
|
13,358 |
|
Loss from
operations |
|
(14,691 |
) |
|
|
(13,358 |
) |
Other income
(expense): |
|
|
|
Interest
income |
|
675 |
|
|
|
256 |
|
Interest
expense |
|
(499 |
) |
|
|
(8 |
) |
Foreign
currency transaction (losses) gains, net |
|
(55 |
) |
|
|
25 |
|
Total
other income, net |
|
121 |
|
|
|
273 |
|
Net loss |
$ |
(14,570 |
) |
|
$ |
(13,085 |
) |
Net loss per share ,
basic and diluted |
$ |
(0.39 |
) |
|
$ |
(0.48 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
37,036,065 |
|
|
|
27,489,397 |
|
|
|
|
|
|
|
|
|
ZAFGEN,
INC. |
CONSOLIDATED BALANCE
SHEETS |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
December 31, |
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
49,331 |
|
|
$ |
40,777 |
|
Marketable securities |
|
68,735 |
|
|
|
61,275 |
|
Tax
incentive receivable |
|
1,536 |
|
|
|
946 |
|
Prepaid
expenses and other current assets |
|
1,728 |
|
|
|
1,927 |
|
Total
current assets |
|
121,330 |
|
|
|
104,925 |
|
Property and equipment,
net |
|
375 |
|
|
|
528 |
|
Other assets |
|
57 |
|
|
|
57 |
|
Total
assets |
$ |
121,762 |
|
|
$ |
105,510 |
|
Liabilities and
Stockholders' Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
3,590 |
|
|
$ |
3,020 |
|
Accrued
expenses |
|
4,261 |
|
|
|
4,273 |
|
Notes
payable, current |
|
5,455 |
|
|
|
- |
|
Total
current liabilities |
|
13,306 |
|
|
|
7,293 |
|
Notes
payable, long-term |
|
15,185 |
|
|
|
20,000 |
|
Total
liabilities |
|
28,491 |
|
|
|
27,293 |
|
Stockholders'
equity: |
|
|
|
Preferred
stock; $0.001 par value per share; 5,000,000 shares authorized
as of December 31, 2018 and 2017; no shares issued and
outstanding as of and December 31, 2018 and 2017 |
|
- |
|
|
|
- |
|
Common
stock, $0.001 par value per share; 115,000,000 shares authorized
as of December 31, 2018 and 2017; 37,287,221 and 27,489,457
shares issued and outstanding as of December 31, 2018 and 2017,
respectively |
|
37 |
|
|
|
27 |
|
Additional paid-in capital |
|
444,212 |
|
|
|
367,825 |
|
Accumulated deficit |
|
(350,945 |
) |
|
|
(289,577 |
) |
Accumulated other comprehensive loss |
|
(33 |
) |
|
|
(58 |
) |
Total
stockholders' equity |
|
93,271 |
|
|
|
78,217 |
|
Total
liabilities and stockholders' equity |
$ |
121,762 |
|
|
$ |
105,510 |
|
|
|
|
|
|
|
|
|
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, 2017.
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