Zafgen, Inc. (Nasdaq:ZFGN) today reported its fourth quarter
and full year 2019 financial results.
In December 2019, Zafgen and Chondrial Therapeutics, Inc.,
announced that the two companies had entered into a definitive
merger agreement. Under the merger agreement, Chondrial
Therapeutics will become a wholly-owned subsidiary of Zafgen, and
the stockholders of Chondrial Therapeutics will become the majority
owners of Zafgen’s outstanding common stock upon the close of the
merger. The proposed merger will result in a combined publicly
traded, clinical-stage biopharmaceutical company operating under a
new name, Larimar Therapeutics, Inc. The transaction is expected to
close in the second quarter of 2020, subject to approvals by
stockholders of each company and other customary closing
conditions.
Chondrial Therapeutics’ lead asset, CTI-1601, is in Phase 1
clinical development for the treatment of Friedreich’s ataxia (FA),
a progressive and irreversible mitochondrial disease caused by a
genetic defect resulting in abnormally low amounts of frataxin. FA
typically presents in childhood or adolescence and leads to
devastating symptoms and early death. The company believes there
are approximately 15,000 patients in the U.S. and E.U. Currently,
there are no cures and no therapies that can modify the course of
the disease. CTI-1601 has received Rare Pediatric Disease
Designation and Fast Track Designation from the U.S. Food and Drug
Administration. Topline results from the Phase 1 clinical program
are expected by the end of 2020.
Fourth Quarter and Full Year 2019 Financial
Results
Cash, Cash Equivalents and Marketable
Securities
As of December 31, 2019, the Company had cash, cash equivalents
and marketable securities totaling $70.3 million.
Net Loss
The Company reported a net loss for the fourth quarter of 2019
of $7.3 million, or $0.19 per share, compared to a net loss of
$14.6 million, or $0.39 per share, for the fourth quarter of 2018.
The net loss for the fourth quarter of 2019 includes $1.5 million
of restructuring charges. For the full year 2019, the Company
reported a net loss of $45.4 million, or $1.22 per
share, compared to $61.4 million, or $1.90 per
share, for the full year 2018. The net loss for the full year 2019
includes $5.6 million of restructuring charges.
The weighted average common shares (basic and diluted)
outstanding used to compute net loss per share were 37.4 million
for the fourth quarter of 2019 compared to 37.0 million for the
same quarter of 2018. For the full year 2019, weighted average
common shares (basic and diluted) outstanding used to compute net
loss per share were 37.3 million compared to 32.2 million for the
full year 2018.
Research and Development Expenses
Research and development expenses for the fourth quarter of 2019
were $0.4 million compared to $11.5 million for the fourth quarter
of 2018. The decrease in research and development expenses compared
to the prior year period was primarily due to the discontinuation
of the MetAP2 program. Research and development expenses in the
fourth quarter of 2019 consist of wind-down costs associated with
closing out the MetAP2 program.
For the full year 2019, research and development expenses were
$23.9 million, compared to $47.9 million for the full year 2018.
The decrease in research and development expenses for the full year
period was primarily due to the decision to discontinue the MetAP2
program during the third quarter of 2019.
Restructuring Charges
Restructuring charges for the fourth quarter and full year 2019
were $1.5 million and $5.6 million, respectively, and include
personnel related costs primarily related to severance expenses as
a result of the multiple reductions in workforce and contract
termination costs implemented during 2019.
General and Administrative Expenses
General and administrative expenses for the fourth quarter of
2019 were $5.3 million, compared to $3.2 million for the fourth
quarter of 2018. The increase in general and administrative
expenses as compared to the prior year period was primarily due to
an increase in professional fees related to strategic alternative
activities and an increase in personnel related costs following the
signing of the definitive merger agreement.
For the full year 2019, general and administrative expenses were
$16.2 million, compared to $13.2 million for the full year 2018.
The increase in general and administrative expenses for the full
year 2019 as compared to the prior year period was primarily due to
an increase in professional fees related to strategic alternative
activities and an increase in personnel related costs following the
signing of the definitive merger agreement.
About ZafgenZafgen (Nasdaq:ZFGN) is a
biopharmaceutical company that has leveraged its proprietary MetAP2
biology platform to pioneer the study of MetAP2 inhibitors in both
common and rare metabolic disorders. Learn more at
www.zafgen.com.
About Chondrial TherapeuticsChondrial
Therapeutics is a clinical-stage biotechnology company focused on
the treatment of complex rare diseases. The company’s lead
compound, CTI-1601, is currently being evaluated in a Phase 1
clinical program as a potential treatment for Friedreich’s ataxia,
a rare and progressive genetic disease. Chondrial Therapeutics also
plans to use its protein replacement therapy platform to design
other fusion proteins to target additional orphan diseases
characterized by deficiencies in intracellular bioactive compounds.
Learn more at www.chondrialtherapeutics.com.
Additional Information about the Proposed Merger and
Where to Find ItThis communication relates to the proposed
merger transaction involving Zafgen, Inc. (“Zafgen”) and Chondrial
Therapeutics, Inc. (“Chondrial”) and may be deemed to be
solicitation material in respect of the proposed merger involving
Zafgen and Chondrial. In connection with the proposed merger,
Zafgen intends to file relevant materials with the Securities and
Exchange Commission (the “SEC”), including a proxy statement
relating to the approval of the merger agreement. Investors
and security holders of Zafgen are urged to read these materials
when they become available because they will contain important
information about Zafgen, Chondrial and the proposed merger. The
proxy statement and other relevant materials (when they become
available), and any other documents filed by Zafgen with the SEC,
may be obtained free of charge at the SEC web site at www.sec.gov.
In addition, investors and security holders may obtain free copies
of the documents filed with the SEC by Zafgen by directing a
written request to: Zafgen, Inc., 3 Center Plaza, Suite 610,
Boston, Massachusetts 02108, Attention: Secretary. Investors
and security holders are urged to read the proxy statement and
other relevant materials when they become available before making
any voting or investment decision with respect to the proposed
merger.
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction.
Participants in the SolicitationZafgen and its
directors and executive officers and Chondrial and its directors
and executive officers may be deemed to be participants in the
solicitation of proxies from the stockholders of Zafgen in
connection with the proposed merger. Information regarding the
special interests of these directors and executive officers in the
proposed merger will be included in the proxy statement referred to
above. Additional information regarding the directors and executive
officers of Zafgen is also included in Zafgen’s definitive proxy
statement in connection with its 2019 Annual Meeting of
Stockholders filed with the SEC on April 26, 2019. These documents
are available free of charge at the SEC web site (www.sec.gov) and
from the Secretary of Zafgen at the address above.
Zafgen Forward-Looking Information is Subject to Risks
and UncertaintyThis communication contains forward-looking
statements based upon Zafgen’s and Chondrial’s current
expectations. Forward-looking statements involve risks and
uncertainties, and include, but are not limited to, statements
about Zafgen’s expected cash, cash equivalents and marketable
securities balance as of December 31, 2019; the structure, timing
and completion of the proposed merger; the combined company’s
listing on Nasdaq after the closing of the proposed merger;
expectations regarding the ownership structure of the combined
company; the combined company’s expected cash position at the
closing of the proposed merger; the future operations of the
combined company; the nature, strategy and focus of the combined
company; the development and commercial potential and potential
benefits of any product candidates of the combined company; the
executive and board structure of the combined company; the location
of the combined company’s corporate headquarters; and other
statements that are not historical fact. Actual results and the
timing of events may differ materially from those indicated by
these forward-looking statements as a result of various important
factors, including, without limitation: (i) the risk that the
conditions to the closing of the proposed merger are not satisfied,
including the failure to timely obtain stockholder approval for the
proposed merger, if at all; (ii) uncertainties as to the
timing of the consummation of the proposed merger and the ability
of each of Zafgen and Chondrial to consummate the proposed merger;
(iii) risks related to Zafgen’s ability to manage its
operating expenses and its expenses associated with the proposed
merger pending closing; (iv) risks related to the failure or
delay in obtaining required approvals from any governmental or
quasi-governmental entity necessary to consummate the proposed
merger; (v) the risk that as a result of adjustments to the
exchange ratio, Zafgen stockholders and Chondrial stockholders
could own more or less of the combined company than is currently
anticipated; (vi) risks related to the market price of
Zafgen’s common stock relative to the exchange ratio;
(vii) unexpected costs, charges, expenditures or expenses
resulting from the proposed merger; (viii) potential adverse
reactions or changes to business relationships resulting from the
announcement or completion of the proposed merger; (ix) Zafgen’s
ability to retain personnel as a result of the announcement or
completion of the proposed merger; and (x) risks associated
with the possible failure to realize certain anticipated benefits
of the proposed merger, including with respect to future financial
and operating results. Actual results and the timing of events may
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties. These and
other risks and uncertainties are more fully described in periodic
filings with the SEC, including the factors described in the
section entitled “Risk Factors” in Zafgen’s most recent Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q filed
with the SEC, and in other filings that Zafgen makes and will make
with the SEC in connection with the proposed merger, including
the proxy statement described above under “Additional
Information about the Proposed Merger and Where to Find It.” You
should not place undue reliance on these forward-looking
statements, which apply only as of the date of this communication.
Zafgen expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in its expectations with
regard thereto or any change in events, conditions or circumstances
on which any such statements are based.
Media/Investor Relations Contacts:Zafgen, Inc.
Patricia Allen Chief Financial Officer 617-648-9792
MediaKrystle GibbsTen Bridge
Communicationskrystle@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, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2017 |
|
Revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
23,886 |
|
|
|
47,929 |
|
|
|
40,839 |
|
General and administrative |
|
|
16,215 |
|
|
|
13,193 |
|
|
|
12,160 |
|
Restructuring charges |
|
|
5,553 |
|
|
|
- |
|
|
|
- |
|
Total operating expenses |
|
|
45,654 |
|
|
|
61,122 |
|
|
|
52,999 |
|
Loss from operations |
|
|
(45,654 |
) |
|
|
(61,122 |
) |
|
|
(52,999 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest income |
|
|
1,989 |
|
|
|
1,889 |
|
|
|
996 |
|
Interest expense |
|
|
(1,766 |
) |
|
|
(1,898 |
) |
|
|
(165 |
) |
Foreign currency transaction gains (losses), net |
|
|
25 |
|
|
|
(237 |
) |
|
|
140 |
|
Total other income (expense), net |
|
|
248 |
|
|
|
(246 |
) |
|
|
971 |
|
Net loss |
|
$ |
(45,406 |
) |
|
$ |
(61,368 |
) |
|
$ |
(52,028 |
) |
Net loss per share, basic and
diluted |
|
$ |
(1.22 |
) |
|
$ |
(1.90 |
) |
|
$ |
(1.90 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
37,347,199 |
|
|
|
32,228,721 |
|
|
|
27,433,239 |
|
ZAFGEN,
INC. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(In
thousands, except share and per share data) |
(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
Revenue |
|
$ |
- |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
423 |
|
|
|
11,457 |
|
General and administrative |
|
|
5,324 |
|
|
|
3,234 |
|
Restructuring charges |
|
|
1,534 |
|
|
|
- |
|
Total operating expenses |
|
|
7,281 |
|
|
|
14,691 |
|
Loss from operations |
|
|
(7,281 |
) |
|
|
(14,691 |
) |
Other income (expense): |
|
|
|
|
Interest income |
|
|
335 |
|
|
|
675 |
|
Interest expense |
|
|
(362 |
) |
|
|
(499 |
) |
Foreign currency transaction gains (losses), net |
|
|
57 |
|
|
|
(55 |
) |
Total other income, net |
|
|
30 |
|
|
|
121 |
|
Net loss |
|
$ |
(7,251 |
) |
|
$ |
(14,570 |
) |
Net loss per share , basic and diluted |
|
$ |
(0.19 |
) |
|
$ |
(0.39 |
) |
Weighted average common shares outstanding, basic and
diluted |
|
|
37,377,223 |
|
|
|
37,036,065 |
|
|
ZAFGEN,
INC. |
|
CONSOLIDATED
BALANCE SHEETS |
|
(In
thousands, except share and per share data) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
27,211 |
|
|
$ |
49,331 |
|
|
Marketable securities |
|
|
43,050 |
|
|
|
68,735 |
|
|
Tax incentive receivable |
|
|
243 |
|
|
|
1,536 |
|
|
Prepaid expenses and other current assets |
|
|
999 |
|
|
|
1,728 |
|
|
Total current assets |
|
|
71,503 |
|
|
|
121,330 |
|
|
Property and equipment,
net |
|
|
821 |
|
|
|
375 |
|
|
Operating lease right-of-use
assets |
|
|
7,051 |
|
|
|
- |
|
|
Restricted cash |
|
|
1,339 |
|
|
|
- |
|
|
Other assets |
|
|
20 |
|
|
|
57 |
|
|
Total assets |
|
$ |
80,734 |
|
|
$ |
121,762 |
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
632 |
|
|
$ |
3,590 |
|
|
Accrued expenses |
|
|
1,190 |
|
|
|
4,261 |
|
|
Accrued restructuring costs |
|
|
2,709 |
|
|
|
- |
|
|
Operating lease liabilities, current |
|
|
386 |
|
|
|
- |
|
|
Notes payable, current |
|
|
7,273 |
|
|
|
5,455 |
|
|
Total current liabilities |
|
|
12,190 |
|
|
|
13,306 |
|
|
Notes payable, long-term |
|
|
8,464 |
|
|
|
15,185 |
|
|
Operating lease liabilities |
|
|
6,456 |
|
|
|
- |
|
|
Total liabilities |
|
|
27,110 |
|
|
|
28,491 |
|
|
Stockholders' equity: |
|
|
|
|
|
Preferred stock; $0.001 par value per share; 5,000,000 shares
authorized as of December 31, 2019 and 2018; no shares
issued and outstanding as of and December 31, 2019 and
2018 |
|
|
- |
|
|
|
- |
|
|
Common stock, $0.001 par value per share; 115,000,000 shares
authorized as of December 31, 2019 and 2018; 37,446,498 and
37,287,221 shares issued and outstanding as of December 31,
2019 and 2018, respectively |
|
|
37 |
|
|
|
37 |
|
|
Additional paid-in capital |
|
|
449,903 |
|
|
|
444,212 |
|
|
Accumulated deficit |
|
|
(396,351 |
) |
|
|
(350,945 |
) |
|
Accumulated other comprehensive loss |
|
|
35 |
|
|
|
(33 |
) |
|
Total stockholders' equity |
|
|
53,624 |
|
|
|
93,271 |
|
|
Total liabilities and stockholders' equity |
|
$ |
80,734 |
|
|
$ |
121,762 |
|
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