NewLink Genetics Corporation
May 5, 2015

NewLink Genetics Corporation Provides Operational Update and Reports First Quarter 2015 Financial Results

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

AMES, Iowa, May 5, 2015 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology medicines to patients with cancer, today reported consolidated financial results for the first quarter of 2015 and progress in its clinical and business development programs.

"NewLink Genetics continued to execute on its immuno-oncology pipeline of products during the first quarter," said Dr. Charles Link, Chairman and Chief Executive Officer. "On the IDO/TDO front, we have successfully launched both our small molecule research and clinical development teams with Genentech, and we are excited about the progress of this partnership. We also accelerated our hiring and pre-commercial activities relating to algenpantucel-L. Finally, we earned a $20 million milestone payment from Merck Inc. on our investigational rVSV-EBOV (Ebola) vaccine candidate, originally developed by the Public Health Agency of Canada. This vaccine has emerged as the only vaccine currently being tested in two of the three large-scale trials in West Africa."

"In addition to working toward the second interim analysis of the IMPRESS clinical trial data, we drove the Company's other key clinical programs forward," said Dr. Nicholas Vahanian, President and Chief Medical Officer. "We are accelerating enrollment in key clinical trials, including PILLAR, and expanding our manufacturing capacity of algenpantucel-L."

Program Updates:

HyperAcute® Cancer Immunotherapy Programs

NewLink Genetics' proprietary cancer immuno-oncology programs may prove to have broad potential across a spectrum of cancer indications, including in combination with checkpoint inhibitors. NewLink Genetics has multiple HyperAcute immunotherapy programs in various stages of clinical development, including pancreatic cancer, lung cancer, and melanoma.

IDO Pathway Inhibitor Program (Proprietary)

We expect to complete enrollment of the following studies with indoximod, our proprietary IDO pathway inhibitor, within the next 12-15 months.

Financial Results for the Three Month Period Ended March 31, 2015

Cash Position: NewLink Genetics ended the quarter on March 31, 2015, with cash, cash equivalents, and certificates of deposit totaling $214.4 million compared to $202.8 million for the year ending December 31, 2014. The increase was attributable primarily to net proceeds received from the milestone payment from Merck & Co., sales under the Company's "at the market" facility (ATM), which was completed in the quarter, and amounts received under government contracts.

R&D Expenses: Research and development expenses in the first quarter of 2015 were $18 million compared to $6.4 million during the comparable period in 2014. The increase is primarily due to clinical trial expenses and the manufacturing and research related to the Ebola vaccine candidate.

G&A Expenses: General and administrative expenses in the first quarter of 2015 were $8.4 million compared to $3.3 million during the comparable period in 2014. The increase was primarily due to an increase in share-based compensation expense, as well as increases in consulting and legal fees, and medical affairs and pre-commercial activities.

Net Income/Loss: NewLink Genetics reported net income of $11.2 million or $0.35 per diluted share for the first quarter of 2015 compared to a net loss of $9.2 million or ($0.33) per diluted share for the comparable period in 2014.

NewLink Genetics received approximately $13.5 million in net proceeds from sales under its ATM during the three months ended March 31, 2015 and ended the quarter with 28,517,195 shares outstanding.

Financial Guidance

NewLink Genetics expects to end the year on December 31, 2015, with approximately $160 million in cash, cash equivalents and certificates of deposit. This guidance recognizes that an early halt in the IMPRESS trial for effectiveness would require the need to accelerate organizational development and spending levels.

"We finished the quarter with a strong cash position and the capacity to make the necessary investments to become a commercial biopharmaceutical company," said Jack Henneman, Executive Vice President and Chief Financial Officer. "Significant investments for the remainder of 2015 will include developing our manufacturing capacity, building our commercialization team, and investments in broadening our pipeline of drug candidates."

Conference Call

The Company has scheduled a conference call for 8:30 a.m. ET today to discuss the results and to provide an update on clinical and business development activities.

NewLink's senior management team will host the conference 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 call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. 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 31502548. The replay will be available for two weeks from the date of the call.

About NewLink Genetics Corporation

NewLink Genetics is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve treatment options for patients with cancer. NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink Genetics' product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens.

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 facts, 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 2015; enrollment in or results of its clinical trials for product candidates; its timing of release of clinical 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, 2014 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 March 31,
  2015 2014
     
Grant revenue  $ 9,649  $ 334
Licensing revenue 29,546
Total revenue 39,195 334
     
Operating expenses:    
Research and development 17,981 6,387
General and administrative 8,366 3,251
     
Income (loss) from operations 12,848 (9,304)
     
Other income (expense), net 11 68
     
Income (loss) before income taxes 12,859 (9,236)
     
Income tax expense (1,669)
     
Net income (loss)  $ 11,190  $ (9,236)
     
Basic earnings per share  $ 0.40  $ (0.33)
     
Diluted earnings per share  $ 0.35  $ (0.33)
     
Basic average shares outstanding 28,218,631 27,605,910
     
Diluted average shares outstanding 31,919,318 27,605,910
 
NewLink Genetics Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands, except share and per share data)
  Year Ended
  March 31, December 31,
  2015 2014
Assets    
Current assets:    
Cash, cash equivalents and certificates of deposit  $ 214,369  $ 202,797
Prepaid expenses, advance payments to vendors and other current assets 22,540 12,062
Income tax receivable 14,190 15,604
Total current assets 251,099 230,463
Property and equipment, net 8,028 7,599
Total assets  $ 259,127  $ 238,062
     
Liabilities and Equity    
Current liabilities:    
Accounts payable and accrued expenses  $ 13,408  $ 11,779
Unearned revenue 3,478 12,966
Other current liabilities 676 276
Total current liabilities 17,562 25,021
Long-term liabilities:    
Royalty obligation payable 6,000 6,000
Notes payable and obligations under capital leases 494 941
Deferred rent 1,216 1,238
Unearned revenue, excluding current portion 1,024 1,085
Total long-term liabilities 8,734 9,264
Total liabilities 26,296 34,285
Stockholder's equity:    
Common stock 285 280
Additional paid-in capital, net 254,966 236,838
Treasury stock, at cost  (491)  (222)
Retained deficit  (21,929)  (33,119)
Total equity 232,831 203,777
Total liabilities and equity  $ 259,127  $ 238,062
CONTACT: Corporate Contact:

         Jack Henneman

         Chief Financial Officer, NewLink Genetics

         515-598-2561

         Investor@linkp.com



         Investors:

         Donna LaVoie

         LaVoieHealthScience

         617-374-8800, ext. 107

         dlavoie@lavoiehealthscience.com



         Media:

         David Connolly

         LaVoieHealthScience

         617-374-8800, ext. 108

         dconnolly@lavoiehealthscience.com

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Source: NewLink Genetics Corporation

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