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NewLink Genetics Reports Third Quarter 2012 Financial Results


10/31/2012 10:01:39 AM

AMES, IA--(Marketwire - October 31, 2012) - 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

  • 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®) 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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