NewLink Genetics Corporation Reports Second Quarter 2013 Financial Results
NewLink reported a net loss for the second quarter 2013 of
Total grant revenues for the second quarter 2013 were
NewLink ended the second quarter with cash, cash equivalents and certificates of deposit totaling
"We presented an array of compelling clinical and preclinical data across our pipeline of novel immunotherapies at some of the most prominent cancer meetings this quarter. This included clinical data on NewLink's HyperAcute immunotherapies and our novel IDO pathway inhibitor, indoximod. In addition, preclinical data on
Second Quarter and Recent Accomplishments
- Algenpantucel-L. Presented clinical data demonstrating encouraging long-term disease-free and overall survival in a Phase 2 clinical study of algenpantucel-L for resected pancreatic cancer at the
American Society of Clinical Oncology(ASCO) 2013 Annual Meeting. Overall survival data from patients with elevated levels of two or more separate biomarkers correlated with a statistically significant improvement relative to those without elevated levels. NewLink's lead product candidate, algenpantucel-L, is being studied in a Phase 3 trial with enrollment of up to 722 patients with surgically resected pancreatic cancer (IMPRESS). Algenpantucel-L is also being tested in a second Phase 3 study involving patients with locally advanced pancreatic cancer (PILLAR).
- Tergenpumatucel-L. Presented positive clinical data demonstrating the potential to improve survival as well as enhancing response rates to subsequent therapies in a Phase 2 clinical study of tergenpumatucel-L for non-small cell lung cancer (NSCLC) at the ASCO 2013 Annual Meeting. In this study tergenpumatucel-L demonstrated activity as a single agent and the potential to enhance salvage chemotherapy efficacy in previously treated patients. Tergenpumatucel-L is the second most advanced product in clinical testing from NewLink's HyperAcute platform technology. In addition, a Phase 2b/3 trial comparing tergenpumatucel-L to docetaxel for patients with previously treated NSCLC is currently underway to further investigate tergenpumatucel-L's potential to produce a chemo-sensitization effect and improve overall survival.
- Indoximod. Presented clinical data demonstrating safety and anti-tumor activity in two Phase 1 studies of indoximod for metastatic tumors when used in combination with other anti-cancer agents. Indoximod was tested in a Phase 1 study in combination with docetaxel and in a Phase 1B/2 study in combination with a dendritic cell cancer vaccine (Ad.p53DC). In both studies, indoximod was well tolerated when combined with these anti-cancer agents and showed promising signs of anti-tumor activity. Indoximod is an orally administered small molecule drug candidate that inhibits the IDO pathway. Two randomized, placebo controlled Phase 2 clinical trials with indoximod in combination with other agents for patients with metastatic breast or prostate cancer are currently underway.
NLG919. Presented preclinical data demonstrating the benefits of targeting the IDO pathway with small molecule immunomodulatory drugs for the treatment of cancer at the 2013 Annual Meeting of the American Association for Cancer Research(AACR). These data demonstrated on target anti-tumor effects and synergy with indoximod as well as favorable oral bioavailability, pharmacokinetic and pharmacodynamic profiles. NLG919is NewLink's second small molecule IDO pathway inhibitor and is expected to enter human clinical trials by the end of this year.
- Added to the NASDAQ Biotechnology Index ®, effective
Monday, May 20, 2013. The NASDAQ Biotechnology Index tracks the performance of a select set of NASDAQ-listed biotechnology and pharmaceutical securities that meet certain eligibility criteria including a minimum market capitalization of $200 millionand minimum average daily trading volume of 100,000 shares. The Index Securitiesserve as the basis for the iShares NASDAQ Biotechnology Index Fund.
NewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve treatment options for patients with cancer. 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. 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 2013; 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
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended
||Six Months Ended
|Research and development||5,037||4,740||11,380||8,570|
|General and administrative||2,264||2,151||4,265||3,609|
|Loss from operations||(7,069||)||(6,301||)||(15,111||)||(11,118||)|
|Other (expense) income, net||(8||)||(8||)||100||(33||)|
|Net loss per common share, basic and diluted||$||(0.28||)||$||(0.31||)||$||(0.61||)||$||(0.54||)|
|Weighted average number of common shares outstanding||25,620,566||20,684,944||24,745,380||20,649,045|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share data)|
|Cash, cash equivalents and certificates of deposit||$||59,039||$||21,744|
|Prepaid expenses and other current assets||2,032||1,645|
|Total current assets||61,071||23,389|
|Property and equipment, net||5,942||6,040|
|Liabilities and Equity|
|Accounts payable and accrued expenses||$||3,893||$||2,631|
|Other current liabilities||186||204|
|Total current liabilities||4,163||2,919|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||1,129||1,178|
|Total long-term liabilities||8,492||8,583|
|Additional paid-in capital, net||173,909||122,514|
|Deficit accumulated during the development stage||(119,808||)||(104,797||)|
|Total stockholders' equity||54,358||17,927|
|Commitments and contingencies||--||--|
|Total liabilities and equity||$||67,013||$||29,429|
Chief Financial Officer
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