NewLink Genetics Corporation Reports Third Quarter 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(R) 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  


 
--  Cash, cash equivalents and certificates of deposit totaled $28.3
    million at September 30, 2012.
--  Total grant revenues for the third quarter 2012 were $327,000 compared
    with $430,000 for the third quarter 2011. Grant revenues will vary
    depending on the level of research funded under grants as well as
    changes in the overhead rates and profit factors agreed to under the
    grants. The decrease in revenue was due to a decrease in research by
    BPS under various Department of Defense contracts and National
    Institutes of Health grants as amended.
--  Research and development (R&D) expense for the third quarter 2012
    was $4.8 million compared with $3.3 million for the third quarter
    2011. The increase was primarily due to increases in clinical trial
    expense associated with an increase in the number of patients enrolled
    in clinical trials and personnel-related expenses
 associated with both
    increased headcounts and increased compensation levels.
--  General and administrative (G&A) expense for the third quarter
    2012 was $1.4 million compared with $1.1 million for the third quarter
    2011. The increase was primarily due to increases in professional and
    Board fees and Directors and Officers insurance premiums associated
    with our new public company status.
--  Net loss for the third quarter 2012 was $5.9 million or $.28 per
    common share (based on 20.9 million weighted average shares
    outstanding), compared with $4.0 million, or $1.09 per common share,
    for the third quarter 2011 (based on 3.7 million weighted average
    shares outstanding). The difference in the number of weighted average
    shares outstanding primarily resulted from NewLink's initial public
    offering in November 2011, as well as the conversion of all preferred
    stock to common stock in connection with the initial public offering.

  
Financial Guidance 
NewLink expects to end 2012 with $20 million to $23 million in cash,
cash equivalents and marketable securities.  
Significant recent events: 


 
--  We have continued to rapidly accrue patients in our 700 patient
    IMPRESS study of algenpantucel-L. We continue to believe this Phase 3
    pivotal study will be fully enrolled in 2013.
--  We launched a Phase 3 clinical trial of algenpantucel-L (HyperAcute
    Pancreas) immunotherapy in patients with borderline resectable or
    locally advanced unresectable pancreatic cancer.
--  We launched an adaptive design Phase 2B/3 clinical trial of
    tergenpumatucel-L (HyperAcute Lung) immunotherapy in patients with
    non-small cell lung cancer.
--  We announced an investigator initiated, randomized, double blind
    placebo controlled Phase 2 study titled "Phase II Study of
    sipuleucel-T (PROVENGE(R)) plus indoximod (D-1MT) in the treatment
    of patients with asymptomatic or minimally symptomatic metastatic
    hormone refractory prostate cancer." This study is done in
    collaboration with Dendreon Corporation (DNDN) and the Masonic Cancer
    Center, University of Minnesota.

  
Upcoming Activities 
NewLink expects to present at the following investor conferences:  


 
--  Jefferies Global Healthcare Conference, November 14-15, in London;
--  9th Annual Lazard Capital Markets Healthcare Conference, November
    13-14, in New York City;
--  Piper Jaffray 24th Annual Healthcare Conference, November 27-28, in
    New York City.

  
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
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 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               
                                (unaudited)                                 
             (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 
                                                                            
Operating                                                                   
 expenses:                                                                  
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                    
                                (unaudited)                                 
             (In thousands, except share and per share amounts)             
                                                                            
                                               September 30,   December 31, 
                                                    2012           2011     
                                               -------------  ------------- 
                                                                            
Assets                                                                      
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 
                                               =============  ============= 

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