Zafgen Reports First Quarter 2019 Operating and Financial Results
Recently announced positive results for second cohort of Phase 2 clinical trial of ZGN-1061
Company is currently in the formal regulatory process related to the clinical hold for ZGN-1061; Update still anticipated in Q2 2019
PATH for PWS study continues enrollment with strong support from PWS community
“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
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,
As of
Net Loss
The Company reported a net loss for the first quarter of 2019 of
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
General and Administrative Expenses
General and administrative expenses for the first 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-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
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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 | ||||
Source: Zafgen, Inc.