NewLink Genetics Corporation
Oct 31, 2012

NewLink Genetics Corporation Reports Third Quarter 2012 Financial Results

AMES, IA -- (Marketwire) -- 10/31/12 -- NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today reported consolidated financial results for the third quarter of 2012. NewLink updated the status of its clinical development programs including its HyperAcute® Pancreas Immunotherapy Phase 3 trial (Immunotherapy for Pancreatic Resectable cancer Survival Study or "IMPRESS").

"As we approach the trigger event for the first interim analysis in our IMPRESS pivotal study, we have continued to execute our plan within the financial guidance we provided at the beginning of this year," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink.

"In addition to our IMPRESS pivotal study for resected pancreatic patients, we have initiated a separate Phase 3 study for patients with locally advanced disease," said Dr. Nicholas Vahanian, NewLink's President and Chief Medical Officer. "If approved this new indication potentially doubles the number of patients who could be treated with algenpantucel-L. We are also expanding our HyperAcute immunotherapy platform by opening a major Phase 2B/3 study in non-small cell lung cancer."

The third quarter 2012 Financial Results

Financial Guidance

NewLink expects to end 2012 with $20 million to $23 million in cash, cash equivalents and marketable securities.

Significant recent events:

Upcoming Activities

NewLink expects to present at the following investor conferences:

About NewLink Genetics Corporation

NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve treatment options for cancer patients. 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 a monotherapy or in combination with other treatment regimens. NewLink's lead product candidate, algenpantucel-L (HyperAcute Pancreas) is being studied in a Phase 3 clinical trial in surgically resected pancreatic cancer patients (under a Special Protocol Assessment with the U.S. FDA) as well as in a separate study in locally advanced pancreatic cancer patients. NewLink has recently launched an adaptive design Phase 2B/3 clinical trial of tergenpumatucel-L (HyperAcute Lung) in patients with non-small cell lung cancer. NewLink is developing indoximod (d-1-methyltryptophan, or D-1MT), a small-molecule, orally bioavailable product candidate from NewLink's proprietary indoleamine-(2, 3)-dioxygenase, or IDO, pathway inhibitor technology. NewLink is studying indoximod in various chemotherapy and immunotherapy combination studies independently and in collaboration with the National Cancer Institute. For more information please visit Patient information is available at

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 2012; 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, 2011, in its Quarterly Report on Form 10-Q for the period ended September 30, 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 Statements of Operations


             (In thousands, except share and per share amounts)

                      Three Months Ended             Nine Months Ended

                 ----------------------------  ----------------------------

                 September 30,  September 30,  September 30,  September 30,

                      2012           2011           2012           2011

                 -------------  -------------  -------------  -------------

Grant revenue    $         327  $         430  $       1,388  $       1,571



Research and

 development             4,779          3,301         13,349         10,276

General and

 administrative          1,396          1,101          5,005          3,553

                 -------------  -------------  -------------  -------------

Loss from

 operations             (5,848)        (3,972)       (16,966)       (12,258)

Other (expense)

 income, net                (3)           (14)           (36)           (20)

                 -------------  -------------  -------------  -------------

Net loss         $      (5,851) $      (3,986) $     (17,002) $     (12,278)

                 =============  =============  =============  =============

Net loss

 attributable to

 NewLink         $      (5,851) $      (3,986) $     (17,002) $     (12,277)

                 =============  =============  =============  =============

Net loss per

 common share,

 basic and

 diluted         $       (0.28) $       (1.09) $       (0.82) $       (3.37)

                 =============  =============  =============  =============

Weighted average

 number of

 common shares

 outstanding        20,887,689      3,658,122     20,729,174      3,647,127

                 =============  =============  =============  =============

                        NewLink Genetics Corporation

                   Condensed Consolidated Balance Sheets


             (In thousands, except share and per share amounts)

                                               September 30,   December 31,

                                                    2012           2011

                                               -------------  -------------


Current assets:

  Cash, cash equivalents and certificates of

   deposit                                     $      28,296  $      41,980

  Prepaid expenses and other current assets              625            808

                                               -------------  -------------

    Total current assets                              28,921         42,788

                                               -------------  -------------

Property and equipment, net                            6,087          5,591

                                               -------------  -------------

Total assets                                   $      35,008  $      48,379

                                               =============  =============

Liabilities and Equity

Current liabilities:

  Accounts payable and accrued expenses        $       2,844  $       3,537

  Deferred rent                                           76            913

  Other current liabilities                              230          6,214

                                               -------------  -------------

    Total current liabilities                          3,150         10,664

                                               -------------  -------------

Long-term liabilities:

  Royalty obligation payable                           6,000             --

  Notes payable and obligations under capital

   leases, excluding current portion                   1,221            942

  Deferred rent, excluding current portion             1,414             --

                                               -------------  -------------

    Total long-term liabilities                        8,635            942

                                               -------------  -------------

Total liabilities                                     11,785         11,606

                                               -------------  -------------

Stockholders' equity:

  Preferred Stock                                         --             --

  Common stock                                           209            206

  Additional paid-in capital                         121,492        118,043

  Deficit accumulated during the development

   stage                                             (98,478)       (81,476)

                                               -------------  -------------

Total NewLink Genetics stockholders' equity           23,223         36,773

                                               -------------  -------------

Total equity                                          23,223         36,773

                                               -------------  -------------

Commitments                                               --             --

Total liabilities and equity                   $      35,008  $      48,379

                                               =============  =============


Gordon Link

Chief Financial Officer


Source: NewLink Genetics Corporation

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