Zafgen Reports Third Quarter 2018 Operating and Financial Results
ZGN-1061 1.8 mg cohort for the Phase 2 proof-of-concept trial now fully enrolled; on track for topline results early 2019
ZGN-1258 nonclinical safety and efficacy data sets presented at
‘PATH for PWS’ natural history study collaboration with FPWR opened for participation; robust enrollment seen in first month
Oral, liver targeted MetAP2 inhibitor ZGN-1345 formally named a development candidate
Company to host conference call today at
“We are excited this quarter about the emerging potential of our broader pipeline,” said
Recent Corporate and Program Highlights
ZGN-1061
- Enrollment for the additional 1.8 mg dose cohort is complete and exceeded our targets. As previously announced, Zafgen initiated this additional cohort of its Phase 2 proof-of-concept clinical trial to explore full MetAP2 target engagement efficacy. Data from this cohort are on track for topline results in early 2019.
ZGN-1258
Zafgen presented three ZGN-1258 posters on nonclinical efficacy and safety at the FPWR Annual ConferenceOctober 4-6 th, 2018. The data presented include:
- ZGN-1258 effects on hyperphagia and obesity, demonstrating nonclinical efficacy results replicating those previously shown with Zafgen’s prior molecule for Prader-Willi syndrome (PWS), and directly aligned with the primary pathologies of PWS
- Novel ZGN-1258 effects on additional behavioral manifestations commonly observed in PWS, such as anxiety and obsessive-compulsive behaviors
- ZGN-1258 differentiation versus prior compound on nonclinical safety measures including cardiovascular (CV) measures
- PATH for PWS, Zafgen’s natural history study collaboration with FPWR, opened enrollment at the FPWR annual conference. There is high interest and engagement from the PWS community around this initiative, and enrollment has been robust since opening, with approximately 190 of the 500-participant goal enrolled in the first month.
Zafgen has successfully completed all of the investigational new drug application (IND) enabling studies necessary for submission of an IND to theU.S. Food and Drug Administration (FDA ), with the exception of one in which the contract research organization (CRO) improperly conducted the study.Zafgen is in the process of completing this last requirement with a different CRO, and now expects the IND allowance and Phase 1 start date in the first quarter of 2019.
ZGN-1345
Zafgen announced that ZGN-1345, an orally dosed MetAP2 inhibitor specifically targeting the liver, has been formally advanced to development candidate stage as a differentiated third asset within the Company’s pipeline. Nonclinical models have shown positive preliminary results in multiple liver disease indications.
Corporate
- On
July 2, 2018 ,Zafgen closed an underwritten public offering of 9.2 million shares of its common stock at a price to the public of$7.50 per share, including 1.2 million shares pursuant to the underwriters' exercise in full of their option to purchase additional common shares. The offering resulted in total gross proceeds of$69.0 million and net proceeds of approximately$64.6 million , after deducting the underwriting discounts and commissions and other offering costs.
Zafgen has continued to add to its management team with key hires that bring significant expertise to areas of focus for the Company including:
-Lisa Percival , Vice President of Regulatory, who brings nearly 20 years of global regulatory experience and previously co-led the Pediatric Center of Excellence atBristol-Myers Squibb (BMS)
-Erin Brubaker , Vice President of Commercial Strategy and Business Development, who brings 25 years of experience including global leadership roles in New Product Planning, Portfolio Strategy, Alliance Management and Commercial while at GlaxoSmithKline (GSK)
Third Quarter 2018 Financial Results
“We ended the quarter with a strong cash position of
Cash,
As of
Net Loss
The Company reported a net loss for the third quarter of 2018 of
The weighted average common shares (basic and diluted) outstanding used to compute net loss per share were 36,619,575 for the third quarter of 2018 compared to 27,483,550 for the same quarter of 2017.
Research and Development Expenses
Research and development expenses for the third quarter of 2018 were
General and Administrative Expenses
General and administrative expenses for the third quarter of 2018 were
2018 Financial Guidance
The Company expects that its cash, cash equivalents and marketable securities balance will be greater than
Conference Call Information
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 collection of medical history and medical events from PATH for PWS participants to inform development and clinical trial design for potential new treatments for PWS, including ZGN-1258, and the use of ZGN-1258, ZGN-1061, ZGN-1345 and other second-generation MetAP2 inhibitors as treatments for metabolic diseases including PWS, type 2 diabetes, liver diseases and obesity 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, may constitute forward-looking statements for 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 collect and analyze medical history and medical events from PATH for PWS participants, the capacity for such data to inform clinical trial design and potential areas for future study, 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 ZGN-1258, ZGN-1061, ZGN-1345 and its other product candidates 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 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 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:
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617-648-9792
Media
Ten Bridge Communications
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Investors
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443-213-0506
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 11,830 | 9,723 | 36,472 | 29,928 | ||||||||||||
General and administrative | 3,339 | 3,117 | 9,959 | 9,713 | ||||||||||||
Total operating expenses | 15,169 | 12,840 | 46,431 | 39,641 | ||||||||||||
Loss from operations | (15,169 | ) | (12,840 | ) | (46,431 | ) | (39,641 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 623 | 266 | 1,214 | 740 | ||||||||||||
Interest expense | (475 | ) | (31 | ) | (1,399 | ) | (157 | ) | ||||||||
Foreign currency transaction (losses) gains, net | (46 | ) | 20 | (182 | ) | 115 | ||||||||||
Total other income (expense), net | 102 | 255 | (367 | ) | 698 | |||||||||||
Net loss | $ | (15,067 | ) | $ | (12,585 | ) | $ | (46,798 | ) | $ | (38,943 | ) | ||||
Net loss per share, basic and diluted | $ | (0.41 | ) | $ | (0.46 | ) | $ | (1.53 | ) | $ | (1.42 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 36,619,575 | 27,483,550 | 30,608,664 | 27,414,314 | ||||||||||||
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
September 30, | December 31, | ||||||||
2018 | 2017 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 45,141 | $ | 40,777 | |||||
Marketable securities | 82,691 | 61,275 | |||||||
Tax incentive receivable | 1,245 | 946 | |||||||
Prepaid expenses and other current assets | 2,392 | 1,927 | |||||||
Total current assets | 131,469 | 104,925 | |||||||
Property and equipment, net | 419 | 528 | |||||||
Other assets | 57 | 57 | |||||||
Total assets | $ | 131,945 | $ | 105,510 | |||||
Liabilities and Stockholders' Equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 2,627 | $ | 3,020 | |||||
Accrued expenses | 4,901 | 4,273 | |||||||
Notes payable, current | 3,636 | — | |||||||
Total current liabilities | 11,164 | 7,293 | |||||||
Notes payable, long-term | 16,844 | 20,000 | |||||||
Total liabilities | 28,008 | 27,293 | |||||||
Stockholders' equity: | |||||||||
Preferred stock; $0.001 par value per share; 5,000,000 shares authorized as of September 30, 2018 and December 31, 2017; no shares issued and outstanding as of September 30, 2018 and December 31, 2017 | — | — | |||||||
Common stock, $0.001 par value per share; 115,000,000 shares authorized as of September 30, 2018 and December 31, 2017; 36,865,817 and 27,489,457 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively | 37 | 27 | |||||||
Additional paid-in capital | 440,303 | 367,825 | |||||||
Accumulated deficit | (336,375 | ) | (289,577 | ) | |||||
Accumulated other comprehensive loss | (28 | ) | (58 | ) | |||||
Total stockholders' equity | 103,937 | 78,217 | |||||||
Total liabilities and stockholders' equity | $ | 131,945 | $ | 105,510 | |||||
Source: Zafgen, Inc.