NewLink Genetics Corporation Reports Third Quarter 2012 Financial Results
"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.
"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.
The third quarter 2012 Financial Results
- Cash, cash equivalents and certificates of deposit totaled
$28.3 million atSeptember 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 variousDepartment of Defense contracts andNational 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 inNovember 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
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 , inLondon ;- 9th Annual
Lazard Capital Markets Healthcare Conference ,November 13-14 , inNew York City ; - Piper Jaffray 24th Annual Healthcare Conference,
November 27-28 , inNew York City .
About
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
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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