NewLink Genetics Reports Fourth Quarter and Full-Year 2012 Financial Results

NewLink Genetics Reports Fourth Quarter and Full-Year 2012 Financial Results 
Conference Call Scheduled for February 28, 2013 
AMES, IA -- (Marketwire) -- 02/28/13 --  NewLink Genetics Corporation
(NASDAQ: NLNK), a biopharmaceutical company focused on discovering,
developing and commercializing cancer therapeutics, today reported
consolidated 2012 financial results and reviewed key 2012
accomplishments. 
"We have made significant progress during this past year. The
enrollment rate in our pivotal phase 3 IMPRESS trial with our active
cellular immunotherapy product candidate for resected pancreatic
cancer, algenpantucel-L, has exceeded our original expectations. We
initiated both a Phase 3 study in patients with locally advanced
pancreatic cancer using algenpantucel-L, and a Phase 2B/3 adaptive
design study to evaluate our active cellular immunotherapy using
tergenpumatucel-L in patients with progressive or relapsed Stage
IIIB/IV non-small cell lung cancer (NSCLC). In addition, we expect to
move our HyperAcute melanoma immunotherapy into controlled phase 2
studies in 2013. We are also expanding our HyperAcute immunotherapy
platform to include different tumor types. Furthermore, we expect to
move the first of these into Phase 1 human studies in the second half
of 2013," commented Dr. Charles Link, Chairman and Chief Executive
Officer of NewLink. "Rapid enrollment rate in our pivotal phase 3
IMPRESS pancreatic cancer study should enable us to complete
enrollment of this trial in the summer of 2013, ahead of our original
schedule." 
Full Year 2012 Financial Results 


 
--  Year-end cash, cash equivalents and marketable securities totaled
    $21.7 million.
--  Total grant revenues for 2012 were $1.7 million compared with $1.9
    million for 2011.
--  Research and development (R&D) expense increased $3.5 million to
    $17.8 million in 2012 due to higher personnel-related expenses and
    increased clinical trial costs.
--  General and administrative (G&A) expense increased $1.4 million to
    $7.1 million in 2012 primarily due to higher personnel-related
    expenses and public-company costs.
--  Net loss for 2012 was $23.3 million compared with $18.1 million in
    2011.

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


 
--  Closed Public Offering with aggregate net proceeds of approximately
    $49.0 million. On February 4, 2013, NewLink closed an underwritten
    public offering of 4.6 million shares of common stock including
    600,000 shares of common stock sold pursuant to the underwriters'
    exercise of their over-allotment option, at a price to the public of
    $11.40 per share.
--  Significant progress in our IMPRESS Phase 3 trial for resected
    pancreatic cancer patients treated with algenpantucel-L. NewLink
    expects the first interim analysis in mid-2013 and completion of
    enrollment in the summer of 2013.
--  Continued Progress in NewLink's HyperAcute platform of IDO pathway
    inhibitor drug candidates. NewLink plans to launch a Phase 2 study in
    metastatic breast cancer evaluating the combination of Taxotere with
    NewLink's indoximod. NewLink also announced the launch of an
    investigator sponsored study evaluating indoximod in combination with
    Dendreon's Provenge(R) in patients with asymptomatic or minimally
    symptomatic metastatic hormone refractory prostate cancer.

  
Upcoming Activities
 NewLink expects to present at the following
conferences: 


 
--  2013 Needham Healthcare Conference, April 30 - May 1, in NYC
--  Jefferies 2013 Global Healthcare Conference taking place June 3-6 in
    NYC
--  American Society of Clinical Oncology (ASCO) 2013 May 31 - June 4,
    2013 in Chicago, IL.

  
Today's Conference Call and Webcast Reminder
 The NewLink management
team will host a conference call discussing the company's financial
results and recent corporate developments on Thursday, February 28,
2013, at 10:00am EST. The call can be accessed by dialing 1-(877)
363-5052 (domestic) or 1-(914) 495-8600 (international) five minutes
prior to the start of the call and providing the passcode 16064630. A
replay of the call will be available approximately two hours after
the completion of the call and can be accessed by dialing 1-(855)
859-2056 (domestic) or 1-(404) 537-3406 (international), providing
the passcode 16064630. The replay will be available for two weeks
from the date of the live call.  
About HyperAcute Immunotherapy 
NewLink's HyperAcute immunotherapy technology is designed to
stimulate the human immune system by exploiting a natural barrier
present in humans that protects against infection being transmitted
from other mammals. This barrier is related to the enzyme, alpha
(1,3) galactosyl transferase, or Alpha-GT, which is expressed in the
cells of lower mammals but not present in human cells. The presence
of this enzyme results in the incorporation of a non-human form of
carbohydrate called alpha (1,3) galactosyl carbohydrates, or
Alpha-Gal, on the surface of expressing cells. Introducing Alpha-Gal
expressing cells to the human immune system activates an immune
response resulting from pre-existing antibodies against Alpha-Gal.
Antibodies directed against the Alpha-Gal epitope are potentially the
most abundant natural antibody in humans and represent approximately
1% of circulating human antibodies. 
NewLink's HyperAcute cancer immunotherapy product candidates are
composed of irradiated, live, allogeneic human cancer cells modified
to express the gene that makes Alpha-Gal epitopes. This exposure to
Alpha-Gal stimulates the human immune system to attack and destroy
the immunotherapy cells on which Alpha-Gal is present by activating
complement, an important component of the immune system capable of
cell destruction. After destruction, NewLink believes the resulting
cellular fragments bound by anti-Alpha-Gal antibodies are processed
by the immune system to elicit an enhanced multi-faceted immune
response to tumor-associated antigens common to both the
immunotherapy and the patient's tumor cells.  
About indoximod and inhibition of the IDO pathway
 IDO pathway
inhibitors, including indoximod, represent a potential breakthrough
approach to cancer therapy using small-molecule, anti-toleragenic
product candidates intended to counteract a key mechanism by which
tumors evade immune-mediated destruction. IDO is an enzyme that
regulates immune response by suppressing T-cell function and enabling
local tumor immune escape. Recent studies have demonstrated that IDO
is overexpressed in many cancers, within both tumor cells as a direct
defense against T-cell attack, and also within antigen presenting
cells in tumor draining lymph nodes whereby IDO promotes peripheral
tolerance to tumor associated antigens (TAAs). When hijacked by
developing cancers in this manner, IDO may facilitate the survival,
growth, invasion, and metastasis of malignant cells expressing TAAs
that might otherwise be recognized and attacked by the immune system
as foreign. Indoximod is currently in multiple Phase 1B/2 studies
evaluating the addition of indoximod to Taxotere in the treatment of
breast cancer and the addition of indoximod to an autologous P-53
Denritic Cell vaccine, also in the treatment of breast cancer
patients. In addition to its clinical indoximod product candidate,
NewLink has an active program directed at synthesizing other IDO
pathway inhibitors. 
About NewLink Genetic
s 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: the prospects of
Algenpantucel-L, Indoximod and our other HyperAcute platforms and
related clinical trials. 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 risks relating to: the initiation of
clinical trials and the completion of enrollment; adverse general
economic and industry conditions; and those risks discussed in "Risk
Factors" and elsewhere in NewLink's Quarterly Report on Form 10-Q for
the period ended September 30, 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 Statements of Operations                             
                                                                            
(in thousands, except                                                       
 share and per share                                                        
 amounts)                       Quarter Ended              Year Ended       
                          ------------------------  ----------------------- 
                            December     December     December    December  
                              31,          31,          31,          31,    
                              2012         2011         2012        2011    
                          -----------  -----------  -----------  ---------- 
                                                                            
Grant revenue             $       299  $       301  $     1,687  $    1,872 
                                                                            
Operating expenses:                                                         
Research and development        4,489        3,979       17,838      14,255 
General and                                                                 
 administrative                 2,103        2,126        7,108       5,679 
                           ----------   ----------   ----------   --------- 
                                                                            
Loss from operations           (6,293)      (5,804)     (23,259)    (18,062)
                                                                            
Other (expense) income,                                                     
 net                              (26)          (6)         (62)        (26)
                           ----------   ----------   ----------   --------- 
                                                                            
Net loss                  $    (6,319) $    (5,810) $   (23,321) $  (18,088)
                          ===========  ===========  ===========  ========== 
                                                                            
Net loss attributable to                                                    
 NewLink                  $    (6,319) $    (5,810) $   (23,321) $  (18,087)
                          ===========  ===========  ===========  ========== 
                                                                            
Net loss per common                                                         
 share, basic and diluted $     (0.30) $     (0.44) $     (1.12) $    (2.98)
                          ===========  ===========  ===========  ========== 
                                                                            
Weighted average number                                                     
 of common shares                                                           
 outstanding               20,929,184   13,237,960   20,779,450   6,064,542 
                          ===========  ===========  ===========  ========== 
                                                                            
                                                                            
                                                                            
NewLink Genetics Corporation                                                
Condensed Consolidated Balance Sheets                                       
                                                                            
(In thousands, except share and per share data)          Year Ended         
                                                 -------------------------- 
                                                 December 31,  December 31, 
                                                     2012          2011     
                                                 ------------  ------------ 
                                                                            
Assets:                                                                     
Current assets:                                                             
  Cash, cash equivalents and certificates of                                
   deposit                                       $     21,744  $     41,980 
  Prepaid expenses and other current assets             1,645           808 
                                                                            
                                                 ------------  ------------ 
    Total current assets                               23,389        42,788 
                                                 ------------  ------------ 
                                                                            
                                                                            
Property and equipment, net                             6,040         5,591 
                                                 ------------  ------------ 
                                                                            
Total assets                                     $     29,429  $     48,379 
                                                 ============  ============ 
                                                                            
                                                                            
                                                                            
                                                 December 31,  December 31, 
                                                     2012          2011     
                                                 ------------  ------------ 
Liabilities and Equity                                                      
Current liabilities:                                                        
  Accounts payable and accrued expenses          $      2,631  $      3,537 
  Deferred rent                                            84           913 
  Other current liabilities                               204         6,214 
                                                                            
                                                 ------------  ------------ 
    Total current liabilities                           2,919        10,664 
                                                 ------------  ------------ 
                                                                            
                                                                            
Long term liabilities:                                                      
  Notes payable                                         7,140           848 
  Obligations under capital leases                         38            94 
  Deferred rent, excluding current portion              1,405            -- 
                                                 ------------  ------------ 
    Total long term liabilities                         8,583           942 
                                                 ------------  ------------ 
    Total liabilities                                  11,502        11,606 
                                                 ------------  ------------ 
                                                                            
Stockholders' equity:                                                       
  Common stock                                            210           206 
  Additional paid-in capital, net                     122,514       118,043 
Deficit accumulated during the development stage     (104,797)      (81,476)
                                                 ------------  ------------ 
Total equity                                           17,927        36,773 
                                                 ------------  ------------ 
Commitments                                                                 
Total liabilities and equity                     $     29,429  $     48,379 
                                                 ============  ============ 

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