NewLink Genetics Provides Operational & Clinical Update, Reports Fourth Quarter, Year-End 2016 Financial Results
- The IDO pathway, which helps cancer escape the patient's immune system, became increasingly
validated as an immuno-oncology target, with clinical data coming from
NewLink Geneticsand others.
- Presented early Phase 2 clinical data of indoximod plus gemcitabine/nab-paclitaxel for the treatment of patients with metastatic pancreatic cancer at the 2016
American Society of Clinical Oncology(ASCO) Annual Meeting, suggesting evidence of safety and clinical activity.
- Presented promising interim Phase 2 clinical data from a cohort of patients with advanced melanoma treated with indoximod plus pembrolizumab at the 2016 ASCO Annual Meeting.
- Our Ebola vaccine candidate (rVSV∆G-ZEBOV GP), partnered with
Merck, received breakthrough therapy designation from the FDAand PRIME status from the European Medicines Agency. In December 2016the final results of the Guineatrial were published on-line in The Lancetand confirmed efficacy of the vaccine.
- Finished 2016 with
$131.5 millionin cash and equivalents.
Anticipated Highlights in 2017
- Our investigators have submitted an abstract to the
American Association for Cancer Research (AACR) on the Phase2 study cohort of patients with advanced melanoma treated with indoximod in combination with pembrolizumab.
- We have been informed by the AACR committee that
our abstract concerning our new chemical entity
NLG802, a novel prodrug of indoximod, has been accepted for a poster presentation. Genentechis expected to update on progress on a Phase 1b study of GDC-0919 in combination with atezolizumab for patients with solid tumors.
- We intend to update progress from the Phase1b, dose-escalation study of indoximod and standard of care therapy in patients with Acute Myeloid Leukemia (AML).
- We expect to finish the year with approximately
$75 millionin cash. This excludes potential payments from partners, the proceeds from any offering, and any costs associated with any strategic acquisitions.
"We are excited to be presenting clinical data for indoximod at upcoming scientific meetings in 2017 beginning at
AACR next month," said
Cash Position: NewLink Genetics ended the year on December 31, 2016, with cash, cash equivalents, and certificates of deposit totaling $131.5 million compared to
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2016 were
Net Loss: NewLink Genetics reported a net loss of $13.5 million or
NewLink Genetics ended 2016 with 29,163,673 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the results and to give an update on clinical and business development activities. NewLink Genetics' senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.
Access to the live conference call is available by dialing (855) 469-0612 (
NewLink Genetics is a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' product candidates are designed to harness multiple components of the immune system to combat cancer. For more information, please visit http://www.newlinkgenetics.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended ||Year Ended |
|Licensing and collaboration revenue||518||1,588||3,526||36,143|
|Research and development||19,490||14,795||93,300||71,414|
|General and administrative||7,182||7,682||33,226||30,689|
|Loss from operations||(13,970||)||(14,825||)||(90,758||)||(33,602||)|
|Other income (expense), net||128||(11||)||247||(41||)|
|Net loss before taxes||(13,842||)||(14,836||)||(90,511||)||(33,643||)|
|Income tax benefit (expense)||336||(6,738||)||5,356||(6,738||)|
|Basic loss per share||$||(0.46||)||$||(0.75||)||$||(2.94||)||$||(1.41||)|
|Diluted loss per share||$||(0.46||)||$||(0.75||)||$||(2.94||)||$||(1.41||)|
|Basic and diluted average shares outstanding||29,147,247||28,788,615||28,979,327||28,586,585|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and certificates of deposit||$||131,490||$||197,800|
|Prepaid expenses and other current assets||30,447||10,342|
|Income tax receivable||5,975||—|
|Total current assets||167,912||208,142|
|Property and equipment, net||6,835||10,400|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||37,192||$||12,422|
|Other current liabilities||322||667|
|Income taxes payable||—||859|
|Total current liabilities||37,905||14,840|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||285||368|
|Unearned revenue, excluding current portion||—||407|
|Total long-term liabilities||7,376||7,928|
|Additional paid-in capital, net||295,535||276,610|
|Total liabilities and equity||$||174,747||$||218,542|
Jack HennemanChief Financial Officer (515) 598-2561 Investor@linkp.com Investors: Beth KurthLaVoieHealthScience 617-374-8800, ext. 106 firstname.lastname@example.org Media: Alison ChenLaVoieHealthScience 617-374-8800, ext. 104 email@example.com
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