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 first quarter 2019
operating and financial results.
“Since our last update, we have continued to concentrate on
addressing the FDA’s comments on the ZGN-1061 IND clinical hold.
The team has generated a substantial amount of new data since
ZGN-1061 was placed on clinical hold, which we believe support a
constructive dialogue with the FDA,” said Jeffrey Hatfield, Chief
Executive Officer. “We still expect to update investors on ZGN-1061
in the second quarter of 2019.”
Corporate Updates
ZGN-1061
- In 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. 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 is currently in the formal regulatory process related to
the previously disclosed clinical hold for ZGN-1061. An update on
ZGN-1061 is still anticipated in Q2 2019.
ZGN-1258
- As previously announced in March 2019, Zafgen suspended plans
to file an investigational new drug (IND) application for ZGN-1258
for Prader-Willi syndrome (PWS), based on an unexpected finding in
muscle tissue in long-term rodent toxicology studies. Zafgen will
provide an update on its plans for ZGN-1258 at a later time, if
warranted, following further evaluation.
- PATH for PWS, Zafgen’s natural history study conducted in
collaboration with the Foundation for Prader-Willi Research (FPWR)
continues enrollment. The data from this study are intended to
inform the development and clinical trial design of potential new
treatments.
Corporate
- In March 2019, 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.
First Quarter 2019 Financial Results
Cash, Cash Equivalents and Marketable
Securities
As of March 31, 2019, the Company had cash, cash equivalents,
and marketable securities totaling $104.7 million.
Net Loss
The Company reported a net loss for the first quarter of 2019 of
$13.1 million, or $0.35 per share, compared to a net loss of $16.0
million, or $0.58 per share, for the first quarter of 2018.
The weighted average common shares (basic and diluted)
outstanding used to compute net loss per share were 37,313,947 for
the first quarter of 2019 compared to 27,541,594 for the same
quarter of 2018.
Research and Development Expenses
Research and development expenses for the first quarter of 2019
were $9.6 million compared to $12.4 million for the first quarter
of 2018. The decrease in research and development expenses compared
to the prior year period was primarily due to decreased clinical
costs related to ZGN-1061 as the results of the second cohort of
the Phase 2 clinical trial in type 2 diabetes were reported in
January 2019. There was also a decrease in the ZGN-1258 program
costs due to the suspension of the program during the first quarter
of 2019. There were also decreases in discovery and screening costs
and non-cash stock-based compensation expense in the first quarter
of 2019 as compared to the first quarter of 2018. These decreases
in research and development costs were partially offset by an
increase in costs related to the ZGN-1345 program as the program
advances as a development stage candidate.
General and Administrative Expenses
General and administrative expenses for the first quarter of
2019 were $3.6 million, compared to $3.3 million for the first
quarter of 2018. 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.
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-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, the collection of medical history and medical
events from PATH for PWS participants to inform development for
potential treatments for Prader-Willi syndrome
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 March 31,
2019, 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
other 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 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, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
Revenue |
|
$ |
- |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
9,631 |
|
|
|
12,433 |
|
General and administrative |
|
|
3,646 |
|
|
|
3,269 |
|
Total operating expenses |
|
|
13,277 |
|
|
|
15,702 |
|
Loss from operations |
|
|
(13,277 |
) |
|
|
(15,702 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
|
642 |
|
|
|
267 |
|
Interest expense |
|
|
(500 |
) |
|
|
(458 |
) |
Foreign currency transaction gains (losses), net |
|
|
23 |
|
|
|
(63 |
) |
Total other income (expense), net |
|
|
165 |
|
|
|
(254 |
) |
Net loss |
|
$ |
(13,112 |
) |
|
$ |
(15,956 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.35 |
) |
|
$ |
(0.58 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
37,313,947 |
|
|
|
27,541,594 |
|
|
|
ZAFGEN, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
March 31, |
|
December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
36,423 |
|
|
$ |
49,331 |
|
Marketable securities |
|
|
68,243 |
|
|
|
68,735 |
|
Tax incentive receivable |
|
|
1,550 |
|
|
|
1,536 |
|
Prepaid expenses and other current assets |
|
|
1,259 |
|
|
|
1,728 |
|
Total current assets |
|
|
107,475 |
|
|
|
121,330 |
|
Property and equipment,
net |
|
|
337 |
|
|
|
375 |
|
Operating lease right-of-use
assets |
|
|
883 |
|
|
|
- |
|
Tax incentive receivable, net
of current portion |
|
|
94 |
|
|
|
- |
|
Restricted cash |
|
|
1,339 |
|
|
|
- |
|
Other assets |
|
|
57 |
|
|
|
57 |
|
Total assets |
|
$ |
110,185 |
|
|
$ |
121,762 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
3,156 |
|
|
$ |
3,590 |
|
Accrued expenses and other |
|
|
3,299 |
|
|
|
4,261 |
|
Notes payable, current |
|
|
7,273 |
|
|
|
5,455 |
|
Total current liabilities |
|
|
13,728 |
|
|
|
13,306 |
|
Notes payable, long-term |
|
|
13,526 |
|
|
|
15,185 |
|
Operating lease liabilities |
|
|
567 |
|
|
|
- |
|
Total liabilities |
|
|
27,821 |
|
|
|
28,491 |
|
Stockholders' equity: |
|
|
|
|
Preferred stock; $0.001 par value per share; 5,000,000 shares
authorized as of March 31, 2019 and December 31,
2018; no shares issued and outstanding as of March 31, 2019
and December 31, 2018 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value per share; 115,000,000 shares
authorized as of March 31, 2019 and December 31,
2018; 37,323,079 and 37,287,221 shares issued and
outstanding as of March 31, 2019 and December 31, 2018,
respectively |
|
|
37 |
|
|
|
37 |
|
Additional paid-in capital |
|
|
446,383 |
|
|
|
444,212 |
|
Accumulated deficit |
|
|
(364,057 |
) |
|
|
(350,945 |
) |
Accumulated other comprehensive loss |
|
|
1 |
|
|
|
(33 |
) |
Total stockholders'
equity |
|
|
82,364 |
|
|
|
93,271 |
|
Total liabilities and stockholders' equity |
|
$ |
110,185 |
|
|
$ |
121,762 |
|
|
|
|
|
|
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