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Zafgen Reports Second Quarter 2018 Operating and Financial Results Phase 1 clinical trial for ZGN-1258 for Prader-Willi syndrome (PWS) expected to begin in the fourth quarter 2018 Multiple ZGN-1258 nonclinical studies ac

Key Takeaway: Zafgen Reports Second Quarter 2018 Operating and Financial Results Phase 1 clinical trial for ZGN-1258 for Prader-Willi syndrome (PWS) expected to begin in the fourth Multiple ZGN-1258 nonclinical studies accepted for presentation at upcoming Foundation for Prader-Willi Resear

Full Press Release Details

Zafgen Reports Second Quarter 2018 Operating and Financial Results
Phase 1 clinical trial for ZGN-1258 for Prader-Willi syndrome (PWS) expected to begin in the fourth
Multiple ZGN-1258 nonclinical studies accepted for presentation at upcoming
Foundation for Prader-Willi Research (FPWR) Annual Conference
Initiated 1.8 mg dosing arm in
ZGN-1061 Phase 2 clinical trial for type 2 diabetes; results from additional arm expected early 2019
Company to host conference call today at 4:30 PM ET
Boston, Mass., August 7, 2018 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 second quarter 2018 financial results.
2018 is an important year of execution on our plan for our novel second-generation MetAP2 pipeline, said Jeffrey Hatfield, Chief Executive
Officer. We ve continued to make significant progress this year, highlighted by positive data from the initial part of our Phase 2 clinical trial of ZGN-1061 in patients with type 2 diabetes, launch
of the natural history study of PWS, advancement towards clinical testing for ZGN-1258, strengthening of our balance sheet, and key personnel additions. We expect this progress to continue throughout the
remainder of 2018 and beyond, with near-term milestones for all of our key pipeline programs.
Recent Corporate and Program Highlights
Second Quarter 2018 Financial Results
The completion of our recent public offering of common stock has provided the Company with additional capital to advance the Company s
pipeline through multiple value-creating milestones, said Patricia Allen, Chief Financial Officer. We ended the quarter with $75.8 million of cash, cash equivalents and marketable securities and raised net proceeds of approximately
$64.6 million from our recent public offering which closed in early July 2018.
Cash, Cash Equivalents and Marketable Securities
As of June 30, 2018, the Company had cash, cash equivalents and marketable securities totaling $75.8 million. In July 2018, the Company
completed an underwritten public offering of its common stock, which included the full exercise of the underwriters option to purchase additional shares, resulting in net proceeds of approximately $64.6 million. After giving effect to the
estimated net proceeds from the Company s public offering of common stock, the unaudited pro forma cash, cash equivalents and marketable securities balance was $140.4 million as of June 30, 2018.
The Company reported a net loss for the second quarter of 2018 of $15.8 million, or $0.57 per share, compared to a net loss of $13.3 million, or
$0.49 per share, for the second quarter of 2017.
The weighted average common shares (basic and diluted) outstanding used to compute net loss per share
were 27,565,064 for the second quarter of 2018 compared to 27,407,408 for the same quarter of 2017.
Research and Development Expenses
Research and development expenses for the second quarter of 2018 were $12.2 million compared to $10.5 million for the second 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 IND enabling studies progressed during the quarter as the
program advances towards the filing of an IND. The increase in research and development expenses was also the result of increased costs associated with the ongoing Phase 2 clinical trial for ZGN-1061. There
were also increases in personnel related costs and non-cash stock-based compensation expense in the second quarter of 2018 as compared to the second quarter of 2017. These increases in research and development
costs were partially offset by a decrease in nonclinical and manufacturing costs associated with our ZGN-1061 program.
General and Administrative Expenses
administrative expenses for the second quarter of 2018 were $3.4 million, compared to $3.0 million for the second 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 as well as an increase in professional fees primarily related to multi-country patent filing costs, partially offset by a decrease in non-cash stock-based compensation
2018 Financial Guidance
expects that its cash, cash equivalents and marketable securities balance will be greater than $100 million as of December 31, 2018.
Conference Call Information
Zafgen will host an investor
conference call today, August 7, 2018 at 4:30 p.m., Eastern Time, to discuss the Company s second quarter 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 9168629. 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 7, 2018 through August 14, 2018 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 9168629.
Zafgen (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 advancing programs for type 2 diabetes, Prader-Willi syndrome and liver diseases. The
Company s lead product candidate, ZGN-1061, a MetAP2 inhibitor for difficult-to-control type 2 diabetes, has successfully
completed the initial part of a Phase 2 clinical trial. 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 and other second-generation MetAP2 inhibitors as treatments for metabolic diseases including Prader-Willi
syndrome, type 2 diabetes and obesity and Zafgen s expectations with respect to the timing and success of its nonclinical studies and clinical trials of ZGN-1258,
ZGN-1061 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 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-1258, ZGN-1061 and its other product candidates and to differentiate ZGN-1258,
ZGN-1061 and its other product candidates from first-generation MetAP2 inhibitors, such as beloranib, the nonclinical and clinical results for ZGN-1258, 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 nonclinical
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 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. 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:
Chief Financial Officer
Ten Bridge Communications
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 2017
Revenue $ $ $ $
Operating expenses:
Research and development 12,209 10,528 24,642 20,205
General and administrative 3,351 3,008 6,620 6,596
Total operating expenses 15,560 13,536 31,262 26,801
Loss from operations (15,560 ) (13,536 ) (31,262 ) (26,801 )
Other income (expense):
Interest income 324 247 591 474
Interest expense (466 ) (53 ) (924 ) (126 )
Foreign currency transaction (losses) gains, net (73 ) (5 ) (136 ) 95
Total other (expense) income, net (215 ) 189 (469 ) 443
Net loss $ (15,775 ) $ (13,347 ) $ (31,731 ) $ (26,358 )
Net loss per share, basic and diluted $ (0.57 ) $ (0.49 ) $ (1.15 ) $ (0.96 )
Weighted average common shares outstanding, basic and diluted 27,565,064 27,407,408 27,553,394 27,379,122
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
June 30, December 31,
2018 2017
Assets
Current assets:
Cash and cash equivalents $ 40,745 $ 40,777
Marketable securities 35,104 61,275
Tax incentive receivable 895 946
Prepaid expenses and other current assets 1,289 1,927
Total current assets 78,033 104,925
Tax incentive receivable 938
Property and equipment, net 472 528
Other assets 357 57
Total assets $ 79,800 $ 105,510
Liabilities and Stockholders Equity
Current liabilities:
Accounts payable $ 3,010 $ 3,020
Accrued expenses 4,448 4,273
Notes payable, current 1,818
Total current liabilities 9,276 7,293
Notes payable, long-term 18,502 20,000
Total liabilities 27,778 27,293
Stockholders equity:
Preferred stock; $0.001 par value per share; 5,000,000 shares authorized as of June 30, 2018 and December 31, 2017; no shares issued and outstanding as of June 30, 2018 and December 31, 2017
Common stock, $0.001 par value per share; 115,000,000 shares authorized as of June 30, 2018 and December 31, 2017; 27,578,989 and 27,489,457 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively 28 27
Additional paid-in capital 373,308 367,825
Accumulated deficit (321,308 ) (289,577 )
Accumulated other comprehensive loss (6 ) (58 )
Total stockholders equity 52,022 78,217
Total liabilities and stockholders equity $ 79,800 $ 105,510
Last updated: Aug 7, 2018