NewLink Genetics Corporation Reports Third Quarter 2013 Financial Results
- Completion of enrollment in pivotal Algenpantucel-L Pancreas Phase 3 trial, progressing enrollment in Phase 2 trial of indoximod and planned clinical trial initiation for our second IDO pathway checkpoint inhibitor drug,
NLG919 , demonstrate significant progress in both cancer immunotherapy technology platforms
NewLink reported a net loss for the third quarter 2013 of
Research and development expense for the third quarter 2013 was
NewLink ended the third quarter with cash and cash equivalents totaling
"We achieved a major milestone in the IMPRESS Phase 3 clinical trial of algenpantucel-L with the successful accrual of 722 subjects with surgically resected pancreatic cancer. Completion of study enrollment is a critical step toward our mission of bringing better treatment options to pancreatic cancer patients who are in desperate need of more promising alternatives," commented Dr.
Third Quarter and Recent Accomplishments
- Algenpantucel-L. Completed patient enrollment of 722 patients with surgically resected pancreatic cancer in the Phase 3 IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) clinical trial. Additionally, a second Phase 3 trial involving patients with locally advanced pancreatic cancer (PILLAR) is currently enrolling patients.
- IDO (indoleamine-(2,3)-dioxygenase) Pathway Inhibition. Enrollment of patients with metastatic breast cancer continues to advance in our randomized Phase 2 study of indoximod in combination with docetaxel. A Phase 1b dose-escalation study of indoximod plus docetaxel in patients with advanced solid tumors showed a favorable safety profile and preliminary signs of efficacy. NewLink plans to initiate a Phase 1 study of its second IDO pathway checkpoint inhibitor,
NLG919 , before the end of the year.
About
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 | ||||||||||||||||
(unaudited) | ||||||||||||||||
(In thousands, except share and per share amounts) | ||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Grant revenue | $ | 265 | $ | 327 | $ | 799 | $ | 1,388 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 6,125 | 4,779 | 17,505 | 13,349 | ||||||||||||
General and administrative | 2,257 | 1,396 | 6,522 | 5,005 | ||||||||||||
Loss from operations | (8,117 | ) | (5,848 | ) | (23,228 | ) | (16,966 | ) | ||||||||
Other (expense) income, net | (6 | ) | (3 | ) | 94 | (36 | ) | |||||||||
Net loss | $ | (8,123 | ) | $ | (5,851 | ) | $ | (23,134 | ) | $ | (17,002 | ) | ||||
Net loss per common share, basic and diluted | $ | (0.32 | ) | $ | (0.28 | ) | $ | (0.92 | ) | $ | (0.82 | ) | ||||
Weighted average number of common shares outstanding | 25,702,043 | 20,887,689 | 25,067,772 | 20,729,174 | ||||||||||||
Condensed Consolidated Balance Sheets | |||||||||||
(unaudited) | |||||||||||
(In thousands, except share and per share data) | |||||||||||
2013 | 2012 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash, cash equivalents and certificates of deposit | $ | 51,964 | $ | 21,744 | |||||||
Prepaid expenses and other current assets | 2,185 | 1,645 | |||||||||
Total current assets | 54,149 | 23,389 | |||||||||
Property and equipment, net | 6,738 | 6,040 | |||||||||
Total assets | $ | 60,887 | $ | 29,429 | |||||||
Liabilities and Stockholders' Equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable and accrued expenses | $ | 4,842 | $ | 2,631 | |||||||
Other current liabilities | 272 | 288 | |||||||||
Total current liabilities | 5,114 | 2,919 | |||||||||
Long-term liabilities: | |||||||||||
Royalty obligation payable | 6,000 | 6,000 | |||||||||
Notes payable, obligations under capital leases | 1,081 | 1,178 | |||||||||
Deferred rent | 1,342 | 1,405 | |||||||||
Total long-term liabilities | 8,423 | 8,583 | |||||||||
Total liabilities | 13,537 | 11,502 | |||||||||
Stockholders' equity: | |||||||||||
Common stock | 257 | 210 | |||||||||
Additional paid-in capital, net | 175,024 | 122,514 | |||||||||
Deficit accumulated during the development stage | (127,931 | ) | (104,797 | ) | |||||||
Total stockholders' equity | 47,350 | 17,927 | |||||||||
Total liabilities and equity | $ | 60,887 | $ | 29,429 | |||||||
Contact:
Chief Financial Officer
515-598-2925
glink@linkp.com
Source:
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