NewLink Genetics Corporation Reports First Quarter 2014 Financial Results
"In 2013, we achieved a major milestone when we completed patient enrollment in our algenpantucel-L pivotal Phase 3 IMPRESS study," commented Dr.
During 2014, the Company plans to continue advancing product development efforts across both HyperAcute and IDO pathway inhibitor platforms. Currently NewLink has six HyperAcute vaccines in various stages of clinical development for multiple indications (pancreas, lung, melanoma, prostate, breast and renal). In 2014, the Company continued expanding the breadth and depth of its IDO pathway inhibitor program. This included additional clinical development for its lead product candidate, indoximod, and also initiation of patient enrollment in a first-in-human clinical study of
"During the first quarter of 2014 at AACR we presented promising pre-clinical data demonstrating the synergistic anti-tumor activity of our IDO pathway inhibitors indoximod and
NewLink reported a net loss of
Research and development expense in the first quarter of 2014 was
General and administrative expense in the first quarter of 2014 was
NewLink ended the quarter on
Recent Accomplishments
- HyperAcute Platform. Completed first interim analysis for Phase 3 IMPRESS clinical trial and DSMC recommended study continuation without modification. Continued advancing the platform across multiple indications including pancreas, lung, melanoma and renal cancer.
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IDO Inhibitors. Presented preclinical data at the
American Association for Cancer Research (AACR) 2014 Annual Meeting demonstrating that combining multiple checkpoint inhibitors that target the IDO (indoleamine-(2,3)-dioxygenase) pathway is effective in reducing local tumor-mediated immunosuppression and providing potential for enhanced anti-tumor activity. These data demonstrated the synergistic effects of combiningNLG919 , indoximod and anti-PD-1/PD-L1/PD-L2 antibodies to block both the IDO and PD pathways resulting in enhanced anti-tumor effects compared to blocking each pathway independently. This synergy was demonstrated in the context of established tumors treated with otherwise ineffective chemo-immunotherapy regimens. -
TDO Inhibitors. A novel class of compounds that mediate TDO (tryptophan-2,3-dioxygenase) activity were also presented at the AACR meeting. These data showed novel compounds with potent and selective TDO inhibition as well as IDO-specific inhibition and dual inhibition of TDO and IDO.
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.
By leveraging its dual cancer immunotherapy platforms, which are designed to harness multiple components of the immune system to combat cancer, NewLink is well positioned to establish a leadership position in immuno-oncology. NewLink's HyperAcute® immunotherapy platform uniquely stimulates the patient's immune system to recognize and attack cancer cells, while its IDO pathway inhibitor platform technology targets a key immune checkpoint and disrupts mechanisms by which tumors evade the patient's immune system. NewLink's broad product pipeline includes biologic and small molecule immunotherapy product candidates designed to treat a wide range of oncology indications either as monotherapy or in combination with other treatment regimens. NewLink's most advanced product candidates include algenpantucel-L and tergenpumatucel-L HyperAcute immunotherapies, currently in Phase 3 clinical development for pancreatic cancer and Phase 2b/3 for non-small cell lung cancer, respectively. The IDO pathway inhibitor platform has two drug candidates currently in development. The first, indoximod, is currently in Phase 2 development for a range of solid tumor cancers. NewLink's second IDO pathway inhibitor,
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 2014; enrollment in its clinical trials for product candidates based on NewLink's HyperAcute and IDO platform technologies; its 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, 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's Annual Report on Form 10-K for the year ended
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| Condensed Consolidated Statement of Operations | ||||||||
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| Three Months Ended | ||||||||
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| 2014 | 2013 | |||||||
| Grant Revenue | $ | 334 | $ | 302 | ||||
| Operating expenses: | ||||||||
| Research and development | 6,387 | 6,343 | ||||||
| General and administrative | 3,251 | 2,001 | ||||||
| Loss from operations | (9,304 | ) | (8,042 | ) | ||||
| Other (expense) income, net | 68 | 108 | ||||||
| Net loss | $ | (9,236 | ) | $ | (7,934 | ) | ||
| Net loss per common share, basic and diluted | $ | (0.33 | ) | $ | (0.33 | ) | ||
| Weighted average common shares outstanding | 27,605,910 | 23,860,469 | ||||||
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| Condensed Consolidated Balance Sheets | ||||||||||
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| 2014 | 2013 | |||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash, cash equivalents and certificates of deposit | $ | 83,962 | $ | 61,540 | ||||||
| Prepaid expenses and other current assets | 1,347 | 2,430 | ||||||||
| Total current assets | 85,309 | 63,970 | ||||||||
| Property and equipment, net | 6,434 | 6,587 | ||||||||
| Total assets | $ | 91,743 | $ | 70,557 | ||||||
| Liabilities and Equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and accrued expenses | $ | 3,358 | $ | 3,603 | ||||||
| Deferred rent | 84 | 84 | ||||||||
| Other current liabilities | 190 | 189 | ||||||||
| Total current liabilities | 3,632 | 3,876 | ||||||||
| Long-term liabilities: | ||||||||||
| Royalty obligation payable | 6,000 | 6,000 | ||||||||
| Notes payable and obligations under capital leases | 986 | 1,033 | ||||||||
| Deferred rent | 1,300 | 1,321 | ||||||||
| Total long-term liabilities | 8,286 | 8,354 | ||||||||
| Total liabilities | 11,918 | 12,230 | ||||||||
| Stockholder's equity: | ||||||||||
| Preferred stock | -- | -- | ||||||||
| Common stock | 279 | 266 | ||||||||
| Additional paid-in capital, net | 224,941 | 194,038 | ||||||||
| Treasury Stock, at cost | (182 | ) | -- | |||||||
| Deficit accumulated during the development stage | (145,213 | ) | (135,977 | ) | ||||||
| Total equity | 79,825 | 58,327 | ||||||||
| Commitments | -- | -- | ||||||||
| Total liabilities and equity | $ | 91,743 | $ | 70,557 | ||||||
Contact:
Chief Financial Officer
515-598-2561
investor@linkp.com
Source:
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