Zafgen Reports Second Quarter 2019 Operating and Financial Results
Agreement reached with U.S.
Topline data from the in vivo study expected by the end of 2019
PATH for PWS study over-enrolled with continued strong support from Prader-Willi syndrome (PWS) community
“Since the beginning of 2019, we have remained focused on gaining clarity on the path forward for ZGN-1061. With the recent alignment with the
Corporate Updates
- In
July 2019 ,Zafgen announced that it had reached agreement with theU.S. Food and Drug Administration (FDA ) on an in vivo animal study design and protocol to establish relevant safety margins for ZGN-1061, its investigational MetAP2 inhibitor in development. The study is designed to translate the data from Zafgen’s newly developed in vitro assays of human endothelial cells and assessment of tissue factor expression with endothelial cells, along with other supportive assays, as it works toward resolving the previously announced clinical hold. Topline data from the in vivo animal study are expected by the end of 2019.
- In
June 2019 ,Zafgen completed its enrollment for PATH for PWS, Zafgen’s natural history study conducted in collaboration with theFoundation for Prader-Willi Research (FPWR). The study over-enrolled in less than one year from its initiation, with approximately 700 participants across multiple age groups and other important segments of the PWS community, versus the initial goal of 500 participants. The data from this study are intended to inform the development and clinical trial design of potential new treatments for PWS.
- In
June 2019 ,Zafgen presented the positive full results of its Phase 2 clinical trial for ZGN‑1061 in an oral presentation at theAmerican Diabetes Association's 79th Scientific Sessions.Zafgen also presented a poster on data demonstrating that treatment with ZGN-1061 improved measures of glycemic control, including insulin sensitivity and beta-cell function.
Second Quarter 2019 Financial Results
Cash,
As of
Net Loss
The Company reported a net loss for the second quarter of 2019 of
The weighted average common shares (basic and diluted) outstanding used to compute net loss per share were 37.3 million for the second quarter of 2019 compared to 27.6 million for the same quarter of 2018.
Research and Development Expenses
Research and development expenses for the second quarter of 2019 were
General and Administrative Expenses
General and administrative expenses for the second quarter of 2019 were
About Zafgen
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-1061, ZGN-1258, 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-1061, ZGN-1258, ZGN-1345 and its other product candidates, Zafgen’s expected cash, cash equivalents and marketable securities balance as of
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443-213-0506
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, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenue | $ | - | $ | - | $ | - | $ | - | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 8,572 | 12,209 | 18,203 | 24,642 | ||||||||||||
General and administrative | 3,618 | 3,351 | 7,264 | 6,620 | ||||||||||||
Total operating expenses | 12,190 | 15,560 | 25,467 | 31,262 | ||||||||||||
Loss from operations | (12,190 | ) | (15,560 | ) | (25,467 | ) | (31,262 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 561 | 324 | 1,203 | 591 | ||||||||||||
Interest expense | (478 | ) | (466 | ) | (978 | ) | (924 | ) | ||||||||
Foreign currency transaction (losses) gains, net | (22 | ) | (73 | ) | 1 | (136 | ) | |||||||||
Total other income (expense), net | 61 | (215 | ) | 226 | (469 | ) | ||||||||||
Net loss | $ | (12,129 | ) | $ | (15,775 | ) | $ | (25,241 | ) | $ | (31,731 | ) | ||||
Net loss per share, basic and diluted | $ | (0.32 | ) | $ | (0.57 | ) | $ | (0.68 | ) | $ | (1.15 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 37,326,853 | 27,565,064 | 37,320,436 | 27,553,394 | ||||||||||||
ZAFGEN, INC. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands, except share and per share data) | ||||||||
(Unaudited) | ||||||||
June 30, | December 31, | |||||||
2019 | 2018 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 37,240 | $ | 49,331 | ||||
Marketable securities | 54,418 | 68,735 | ||||||
Tax incentive receivable | 1,532 | 1,536 | ||||||
Prepaid expenses and other current assets | 811 | 1,728 | ||||||
Total current assets | 94,001 | 121,330 | ||||||
Property and equipment, net | 968 | 375 | ||||||
Operating lease right-of-use assets | 7,342 | - | ||||||
Tax incentive receivable, net of current portion | 214 | - | ||||||
Restricted cash | 1,339 | - | ||||||
Other assets | 20 | 57 | ||||||
Total assets | $ | 103,884 | $ | 121,762 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,056 | $ | 3,590 | ||||
Accrued expenses | 3,516 | 4,261 | ||||||
Operating lease liabilities, current | 618 | - | ||||||
Notes payable, current | 7,273 | 5,455 | ||||||
Total current liabilities | 13,463 | 13,306 | ||||||
Notes payable, long-term | 11,853 | 15,185 | ||||||
Operating lease liabilities | 6,429 | - | ||||||
Total liabilities | 31,745 | 28,491 | ||||||
Stockholders' equity: | ||||||||
Preferred stock; $0.001 par value per share; 5,000,000 shares authorized as of June 30, 2019 and December 31, 2018; no shares issued and outstanding as of June 30, 2019 and December 31, 2018 |
- | - | ||||||
Common stock, $0.001 par value per share; 115,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 37,326,895 and 37,287,221 shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively |
37 | 37 | ||||||
Additional paid-in capital | 448,258 | 444,212 | ||||||
Accumulated deficit | (376,186 | ) | (350,945 | ) | ||||
Accumulated other comprehensive income (loss) | 30 | (33 | ) | |||||
Total stockholders' equity | 72,139 | 93,271 | ||||||
Total liabilities and stockholders' equity | $ | 103,884 | $ | 121,762 | ||||
Source: Zafgen, Inc.