NewLink Genetics Corporation
Feb 28, 2017

NewLink Genetics Provides Operational & Clinical Update, Reports Fourth Quarter, Year-End 2016 Financial Results

Management to Host Conference Call and Webcast Today at 8:30 a.m. ET

AMES, Iowa, Feb. 28, 2017 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, today reported consolidated financial results for the fourth quarter and year ended 2016, as well as progress in its clinical development programs. NewLink Genetics also outlined key 2017 business priorities related to the clinical development programs for the Company's immuno-oncology pipeline.

"NewLink Genetics has two separate and distinct IDO pathway inhibitors in clinical development. In 2017, we look forward to advancing clinical validation of IDO as an immuno-oncology target," said Charles J. Link, Jr. MD, Chairman, Chief Executive Officer and Chief Scientific Officer. "Our priorities going into 2017 are clear.  For GDC-0919, we anticipate continued progress in the clinic in collaboration with our partner Genentech/Roche.  We believe indoximod will emerge as one of the leading IDO pathway inhibitor programs in 2017."

2016 Highlights

Anticipated Highlights in 2017

"We are excited to be presenting clinical data for indoximod at upcoming scientific meetings in 2017 beginning at AACR next month," said Nicholas Vahanian, M.D., President and Chief Medical Officer.

Financial Results

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 $197.8 million for the year ending December 31, 2015. The Company's cash position is sufficient to fund current operations in the near and medium term.

R&D Expenses: Research and development expenses were $19.5 million and $93.3 million in the fourth quarter and year ended December 31, 2016 compared to $14.8 million and $71.4 million during the comparable periods in 2015. The increase year-over-year was due primarily to $11.1 million of charges incurred as a result of the restructuring during the second quarter of 2016, including a non-cash charge of $4.0 million related to impaired assets, with the remainder of the increase due to increases in contract manufacturing costs, supplies and equipment and clinical trial expenses.

G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2016 were $7.2 million and $33.2 million compared to $7.7 million and $30.7 million during the comparable periods in 2015. The increase was due to an increase of $2.9 million in personnel-related expenses due to changes in transiently increased staffing levels, share-based compensation expense and compensation increases, an increase of $500,000 due to charges incurred as a result of the restructuring, offset by a decrease of $930,000 in consulting, legal and licensing fees, and supplies.

Net Loss: NewLink Genetics reported a net loss of $13.5 million or $0.46 per diluted share for the fourth quarter of 2016 and a net loss of $85.2 million or $2.94 per diluted share for the year ended December 31, 2016, compared to a net loss of $21.6 million or $0.75 per diluted share for the fourth quarter of 2015 and a net loss of $40.4 million or $1.41 per diluted share for the year ended December 31, 2015.

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 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link to the webcast can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Events and Presentations." To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.  A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 71940747. The replay will be available for two weeks from the date of the call.

About NewLink Genetics Corporation

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 NewLink Genetics' financial guidance for 2017; results of its clinical trials for product candidates; its timing of release of data from ongoing clinical studies; its plans related to moving additional indications into clinical development; NewLink Genetics' future financial performance, results of operations, cash position and sufficiency of capital resources to fund its operating requirements; and any other statements other than statements of historical fact.  Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink Genetics' Annual Report on Form 10-K for the year ended December 31, 2015 and other reports filed with the U.S. Securities and Exchange Commission (SEC).  The forward-looking statements in this press release represent NewLink's views as of the date of this press release. NewLink anticipates that subsequent events and developments will cause its views to change.  However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.  You should, therefore, not rely on these forward-looking statements as representing NewLink Genetics' views as of any date subsequent to the date of this press release.



NewLink Genetics Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(In thousands, except share and per share amounts)
        
 Three Months Ended December 31, Year Ended December 31,
 2016 2015 2016 2015
Grant revenue$12,184  $6,064  $32,242  $32,358 
Licensing and collaboration revenue518  1,588  3,526  36,143 
Total revenue12,702  7,652  35,768  68,501 
Operating expenses:       
Research and development19,490  14,795  93,300  71,414 
General and administrative7,182  7,682  33,226  30,689 
Loss from operations(13,970) (14,825) (90,758) (33,602)
Other income (expense), net128  (11) 247  (41)
Net loss before taxes(13,842) (14,836) (90,511) (33,643)
Income tax benefit (expense)336  (6,738) 5,356  (6,738)
Net loss$(13,506) $(21,574) $(85,155) $(40,381)
Basic loss per share$(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 outstanding29,147,247  28,788,615  28,979,327  28,586,585 


NewLink Genetics Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands)
 Year Ended
 December 31, December 31,
 2016 2015
Assets   
Current assets:   
Cash, cash equivalents and certificates of deposit$131,490  $197,800 
Prepaid expenses and other current assets30,447   10,342 
Income tax receivable5,975   
Total current assets167,912  208,142 
Property and equipment, net6,835  10,400 
Total assets$174,747  $218,542 
    
Liabilities and Stockholders' Equity   
Current liabilities:   
Accounts payable and accrued expenses$37,192  $12,422 
Unearned revenue 391  892 
Other current liabilities322  667 
Income taxes payable  859 
Total current liabilities37,905  14,840 
Long-term liabilities:   
Royalty obligation payable6,000  6,000 
Notes payable and obligations under capital leases285   368 
Deferred rent1,091  1,153 
Unearned revenue, excluding current portion  407 
Total long-term liabilities7,376  7,928 
Total liabilities45,281  22,768 
Stockholders' equity:   
Common stock292  288 
Additional paid-in capital, net295,535  276,610 
Treasury stock, at cost(853) (771)
Retained deficit(165,508) (80,353)
Total equity129,466  195,774 
Total liabilities and equity$174,747  $218,542 
    
Corporate Contact:

Jack Henneman

Chief Financial Officer

(515) 598-2561

Investor@linkp.com



Investors:

Beth Kurth

LaVoieHealthScience

617-374-8800, ext. 106

bkurth@lavoiehealthscience.com



Media:

Alison Chen

LaVoieHealthScience

617-374-8800, ext. 104

achen@lavoiehealthscience.com

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