NewLink Genetics Corporation
May 6, 2013
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NewLink Genetics Corporation Reports First Quarter 2013 Financial Results

AMES, IA -- (Marketwired) -- 05/06/13 -- NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapies to improve treatment options for patients with cancer, today reported consolidated financial results for the first quarter of 2013.

"We are looking forward to completing patient accrual for our IMPRESS trial of algenpantucel-L for surgically resected pancreatic cancer. It was also encouraging to see additional clinical trials of both our HyperAcute and IDO product candidates advancing this past quarter," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. "In addition, NewLink presented preclinical results for our second IDO pathway inhibitor drug candidate, NLG919, at the American Association for Cancer Research annual meeting. Based on these data, we plan to initiate a clinical trial with NLG919 later this year, further expanding our clinical development programs."

First Quarter and Recent Accomplishments

Pipeline:

Corporate:

Upcoming Activities

NewLink expects to present at the following conferences:

First Quarter 2013 Financial Results

Financial Guidance

NewLink expects to end 2013 with about $40 million in cash, cash equivalents and marketable securities.

About NewLink Genetics Corporation

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapies 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's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as monotherapies or in combination with other treatment regimens.

NewLink's lead product candidate, algenpantucel-L (HyperAcute® pancreas), is being studied in our IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) Phase 3 trial for patients with surgically resected pancreatic cancer (under a Special Protocol Assessment with the U.S. FDA). Algenpantucel-L is being tested in a second Phase 3 study (PILLAR, "Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable") for patients with locally advanced pancreatic cancer. NewLink is also testing tergenpumatucel-L, an additional HyperAcute® product candidate, in an adaptive design randomized Phase 2B/3 clinical trial currently accruing up to 240 patients with non-small cell lung cancer.

NewLink is also actively developing two small-molecule, IDO (indoleamine-(2, 3)-dioxygenase) pathway inhibitors. The most advanced is indoximod, an orally bioavailable product candidate, that is being studied in various chemotherapy and immunotherapy combination clinical studies. NewLink's second IDO pathway inhibitor, NLG919, has shown promising preclinical results and is expected to enter clinical trials by the end of 2013. For more information please visit http://www.linkp.com. Patient information is available at http://www.pancreaticcancer-clinicaltrials.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 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's financial guidance for 2013; the timing for completion of enrollment of our Phase 3 clinical trial for our HyperAcute Pancreas cancer immunotherapy; the timing of release of clinical data from ongoing clinical studies; its plans related to moving additional indications into clinical development; NewLink's future financial performance, results of operations or 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's Annual Report on Form 10-K for the period ended December 31, 2012, Form S-3 Registration Statement filed December 28, 2012 and in its other filings with the Securities and Exchange Commission. 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's views as of any date subsequent to the date of this press release.

NewLink Genetics Corporation
Condensed Consolidated Statement of Operations
(unaudited)
(In thousands, except share and per share amounts)
Three Months Ended
March 31,
2013 2012
Grant Revenue $ 302 $ 471
Operating expenses:
Research and development 6,343 3,830
General and administrative 2,001 1,458
Loss from operations (8,042 ) (4,817 )
Other (expense) income, net 108 (25 )
Net loss $ (7,934 ) $ (4,842 )
Net loss attributable to NewLink $ (7,934 ) $ (4,842 )
Net loss per common share, basic and diluted $ (0.33 ) $ (0.23 )
Weighted average common shares outstanding 23,860,469 20,613,146

NewLink Genetics Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands, except share and per share data)
March 31, December 31,
2013 2012
Assets
Current assets:
Cash, cash equivalents and certificates of deposit $ 64,025 $ 21,744
Prepaid expenses and other current assets 1,741 1,645
Total current assets 65,766 23,389
Property and equipment, net 5,889 6,040
Total assets $ 71,655 $ 29,429
Liabilities and Equity
Current liabilities:
Accounts payable and accrued expenses $ 2,880 $ 2,631
Deferred rent 84 84
Other current liabilities 177 204
Total current liabilities 3,141 2,919
Long-term liabilities:
Royalty obligation payable 6,000 6,000
Notes payable and obligations under capital leases 1,136 1,178
Deferred rent 1,384 1,405
Total long-term liabilities 8,520 8,583
Total liabilities 11,661 11,502
Stockholder's equity:
Preferred stock -- --
Common stock 256 210
Additional paid-in capital, net 172,469 122,514
Deficit accumulated during the development stage (112,731 ) (104,797 )
Total NewLink Genetics stockholders' equity 59,994 17,927
Total equity 59,994 17,927
Commitments -- --
Total liabilities and equity $ 71,655 $ 29,429

Contact:
Gordon Link
Chief Financial Officer
515-598-2925
glink@linkp.com

Source: NewLink Genetics Corporation

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