NewLink Genetics Corporation Provides Operational Update And Reports Third Quarter 2016 Financial Results

AMES, Iowa, Nov. 01, 2016 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology therapies to patients with cancer, today reported consolidated financial results for the third quarter of 2016 and progress in its clinical and pipeline development programs.

"We continue to focus our clinical developmental efforts targeting the IDO pathway.  We have two distinct IDO pathway inhibitors advancing in the clinic, GDC-0919 with our partner Genentech and indoximod, our proprietary IDO pathway inhibitor," said Charles J. Link, Jr. MD, Chairman, Chief Executive Officer and Chief Scientific Officer.  "We are also encouraged by recent clinical data that increasingly validate the IDO pathway as an important target in immuno-oncology."

The Company hosted an investor day on October 25, outlining its vision and execution plans for the future.  A webcast of the Company's presentations can be found at http://investors.linkp.com/events.cfm. 

"As described at our investor day, we believe 2017 will be an important year in the development of both GDC-0919 and indoximod and we look forward to providing further updates and results," added Nicholas N. Vahanian, MD, President and Chief Medical Officer.

The program featured leaders in the field of immuno-oncology and pioneers in the science of IDO:  George C. Prendergast, PhD, President & CEO, Lankenau Institute for Medical Research (LIMR) and Editor in Chief, Cancer Research; David H. Munn, MD, Professor of Pediatric Hematology-Oncology, Medical College of Georgia, Augusta University; Montaser Shaheen MD, Associate Professor, University of New Mexico Cancer Center; and Ashkan Emadi, MD, PhD, Associate Professor, University of Maryland.

Key takeaways from the Investor Day included:

1. Validation of IDO as a Target. The IDO pathway can allow cancer to escape the immune system. Many cancers have developed the ability to employ IDO to evade immune attack.  We believe clinical results are increasingly validating the IDO pathway as a target for cancer therapies. Just as scientists discovered the role of PD-1/PD-L1 expression and the usefulness of PD-1/PD-L1 blockade, there is an increasing body of research into the role of the IDO pathway in cancer.

2. NewLink's Two IDO Pathway Inhibitor Clinical Candidates. NewLink Genetics is engaged in clinical trials for two IDO pathway inhibitor product candidates, each with its own distinct mechanism of action.
  • GDC-0919, a direct IDO enzymatic inhibitor, is being developed in partnership with Genentech. GDC-0919 is currently in a Phase 1b trial, in combination with atezolizumab in solid tumors. In October, 2014, NewLink and Genentech entered in to a license and collaboration agreement with an upfront payment of $150 million, more than $1 billion in potential milestones, and substantial royalties.
  • Indoximod, an IDO pathway inhibitor, is proprietary to NewLink Genetics. Indoximod is being tested in the clinic in multiple indications including melanoma, pancreatic cancer, malignant brain tumors, breast cancer, acute myeloid leukemia, and non-small cell lung cancer.

3. Indoximod Clinical Development. The Company reported that it will evaluate the data and report on several clinical trials underway in 2017.  Furthermore, our clinical development strategy for indoximod includes formulation optimization intended to improve the candidate's clinical and commercial potential.

4. Future R&D. NewLink also discussed its program targeting the PTEN pathway in regulatory T cells (Treg cells) as a central driver of tumor immunosuppression. NewLink Genetics is an early leader in the field of PTEN research, just as it was in developing IDO as a potential pathway for immune suppression in cancer.

Financial Results for the Three-Month Period Ended September 30, 2016

Cash Position: NewLink Genetics ended the quarter on September 30, 2016, with cash and equivalents totaling $148.3 million, compared to $197.8 million for the year ending December 31, 2015.

R&D Expenses: Research and development expenses in the third quarter of 2016 were $24.5 million, compared to $22.5 million during the comparable period in 2015.  The increase was primarily due to a $3.2 million increase in contract manufacturing costs, a $340,000 increase in stock compensation expense, and a $400,000 increase in clinical trial expenses, offset by a decrease in equipment and supplies of $1.3 million, wages of $490,000 and a $160,000 decrease in consulting.

G&A Expenses: General and administrative expenses in the third quarter of 2016 were $7.7 million compared to $7.4 million during the comparable period in 2015. The increase was due primarily to an increase of $300,000 in consulting and personnel-related expenses.

Net Income/Loss: NewLink Genetics reported a net loss of $15.5 million, or a loss of $0.54 per diluted share, for the third quarter of 2016, compared to a net loss of $15.9 million, or a loss of $0.55 per diluted share, for the comparable period in 2015.

NewLink Genetics ended the quarter with 29,091,652 shares outstanding.

Financial Guidance and Upcoming Investor Meetings

NewLink Genetics expects to have approximately $132 million in cash and equivalents on December 31, 2016.

We have presented at seven investor meetings and conferences since the beginning of the year, including our own investor day held last week. We expect to present at three upcoming conferences in New York City, including the Global Mizuho Investor Conference on November 14, the Stifel 2016 Healthcare Conference on November 15, and the Piper Jaffray 28 th Annual Healthcare Conference on November 29.

Conference CallThe Company has scheduled a conference call for 8:30 a.m. ET today to discuss these results and to provide an update on clinical and pipeline development programs. NewLink Genetics' senior management team will host the conference call, which will be open to all listeners.  There will also be a question and answer session following the prepared remarks. Access to the live call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call.  A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 5960440.

About NewLink Genetics CorporationNewLink Genetics is a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' product candidates are designed to harness multiple components of the immune system to combat cancer.  For more information, please visit http://www.newlinkgenetics.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 fact, 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 Genetics' financial guidance for 2016; results of its clinical trials for product candidates; its timing of release of data from ongoing clinical studies; its plans related to moving additional indications into clinical development; NewLink Genetics' future financial performance, results of operations, cash position and 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 Genetics' Annual Report on Form 10-K for the year ended December 31, 2015 and other reports filed with the U.S. Securities and Exchange Commission (SEC).  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 Genetics' 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 September 30,   Nine Months Ended September 30,
  2016   2015   2016   2015
Grant revenue $ 14,457     $ 13,365     $ 20,057     $ 26,294  
Licensing and collaboration revenue 888     844     3,008     34,555  
Total revenue 15,345     14,209     23,065     60,849  
Operating expenses:              
Research and development 24,463     22,508     73,810     56,619  
General and administrative 7,749     7,384     26,043     23,007  
Loss from operations (16,867 )   (15,683 )   (76,788 )   (18,777 )
Other income (expense), net 19     (63 )   118     (30 )
Net loss before taxes (16,848 )   (15,746 )   (76,670 )   (18,807 )
Income tax benefit (expense) 1,308     (160 )   5,021      
Net loss $ (15,540 )   $ (15,906 )   $ (71,649 )   $ (18,807 )
Basic and diluted loss per share $ (0.54 )   $ (0.55 )   $ (2.48 )   $ (0.66 )
Basic and diluted average shares outstanding 28,983,561     28,734,768     28,911,042     28,518,503  

NewLink Genetics Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands)
   
  September 30,   December 31,
  2016   2015
Assets      
Current assets:      
Cash, cash equivalents and certificates of deposit $ 148,276     $ 197,800  
Prepaid expenses and other current assets 25,683     10,342  
Income tax receivable 5,197      
Total current assets 179,156     208,142  
Property and equipment, net 7,188     10,400  
Total assets $ 186,344     $ 218,542  
       
Liabilities and Stockholders' Equity      
Current liabilities:      
Accounts payable and accrued expenses $ 39,626     $ 12,422  
Unearned revenue 693     892  
Other current liabilities 326     667  
Income taxes payable     859  
Total current liabilities 40,645     14,840  
Long-term liabilities:      
Royalty obligation payable 6,000     6,000  
Notes payable and obligations under capital leases 333     368  
Deferred rent 1,089     1,153  
Unearned revenue     407  
Total long-term liabilities 7,422     7,928  
Total liabilities 48,067     22,768  
Stockholders' equity:      
Common stock 291     288  
Additional paid-in capital 290,772     276,610  
Treasury stock, at cost (784 )   (771 )
Accumulated deficit (152,002 )   (80,353 )
Total stockholders' equity 138,277     195,774  
Total liabilities and stockholders' equity $ 186,344     $ 218,542  
       

 
Corporate Contact:Jack HennemanChief Financial Officer, NewLink Genetics515-598-2561Investor@linkp.comInvestors:Donna LaVoieLaVoieHealthScience617-374-8800, ext. 107dlavoie@lavoiehealthscience.comMedia:David ConnollyLaVoieHealthScience617-374-8800, ext. 108dconnolly@lavoiehealthscience.com

Primary Logo