NewLink Genetics Corporation Reports Second Quarter 2012 Financial Results
"Data from the Phase 2 study of our HyperAcute pancreatic cancer immunotherapy was successfully presented at two major conferences and continues to support our Phase 3 study design," commented Dr.
Dr. Nicholas Vahanian NewLink's President and Chief Medical Officer added; "Recent positive data from Phase 2 studies in three different HyperAcute cancer immunotherapies have given us confidence to move forward aggressively in the clinical development of multiple therapies derived from this platform."
The second quarter 2012 Financial Results
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Cash, cash equivalents and certificates of deposit totaled
$31.1 million atJune 30, 2012 . -
Total grant revenues for the second quarter 2012 were
$590,000 compared with$537,000 for the second 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 increase in revenue was due to increased research under variousDepartment of Defense contracts andNational Institutes of Health grants. -
Research and development (R&D) expense for the second quarter 2012 was
$4.7 million compared with$3.8 million for the second quarter 2011. The increase was primarily due to increases in personnel-related expenses associated with both increased headcounts and increased compensation levels in addition to increased clinical trial expense associated with an increase in the number of patients enrolled in clinical trials. -
General and administrative (G&A) expense for the second quarter 2012 was
$2.2 million compared with$1.1 million for the second quarter 2011. The increase was primarily due to increases in personnel-related expenses as well as increases in professional and Board fees and Directors and Officers insurance premiums associated with our new public company status. -
Net loss for the second quarter 2012 was
$6.3 million or$.31 per common share (based on 20.7 million weighted average shares outstanding), compared with$4.4 million , or$1.20 per common share, for the second quarter 2011 (based on 3.6 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 is maintaining its financial guidance and continues to expect to end 2012 with about
Recap of Data From Phase-2 HyperAcute® Pancreas (algenpantucel-L) Immunotherapy Trial:
Treated patients demonstrated statistically significant improvement in 12-month disease free survival and there was a strong suggestion of improvements in 12 month overall survival (OS) (observed 86% v. predicted 63% indicating a 37% improvement). Kaplan-Meier analysis suggests the improvement in OS increases over time with the 2-year and 3-year observed survival rates of 51% and 42% suggesting relative improvement of 59% and 121% in comparison to expected survival of 32% and 19% predicted by nomogram analysis.
Upcoming Activities
NewLink expects to present at the following investor conferences:
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2nd Annual
Canaccord Global Growth Conference ,August 14-16 , inBoston, MA. -
Stifel Nicolaus Weisel Healthcare Conference 2012,September 4-7 , inBoston, MA. -
Robert W. Baird Health Care Conference ,September 5-6 , inNew York City . -
9th Annual
Lazard Capital Markets Healthcare Conference ,November 13-14 , 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
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Condensed Consolidated Statements of Operations | ||||
(unaudited) | ||||
(In thousands, except share and per share amounts) | ||||
Three Months Ended | Six Months Ended | |||
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2012 | 2011 | 2012 | 2011 | |
Grant revenue |
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Operating expenses: | ||||
Research and development | 4,740 | 3,795 | 8,570 | 6,975 |
General and administrative | 2,151 | 1,136 | 3,609 | 2,452 |
Loss from operations | (6,301) | (4,394) | (11,118) | (8,286) |
Other (expense) income, net | (8) | — | (33) | (6) |
Net loss |
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Net loss attributable to NewLink |
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Net loss per common share, basic and diluted |
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Weighted average number of common shares outstanding | 20,684,944 | 3,646,973 | 20,649,045 | 3,641,539 |
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Condensed Consolidated Balance Sheets | ||
(unaudited) | ||
(In thousands, except share and per share amounts) | ||
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2012 | 2011 | |
Assets | ||
Current assets: | ||
Cash, cash equivalents and certificates of deposit |
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Prepaid expenses and other current assets | 1,797 | 808 |
Total current assets | 32,871 | 42,788 |
Property and equipment, net | 6,265 | 5,591 |
Total assets |
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Liabilities and Equity | ||
Current liabilities: | ||
Accounts payable and accrued expenses |
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Deferred rent | 71 | 913 |
Other current liabilities | 204 | 6,214 |
Total current liabilities | 2,616 | 10,664 |
Long-term liabilities: | ||
Royalty obligation payable | 6,000 | — |
Notes payable and obligations under capital leases, excluding current portion | 854 | 942 |
Deferred rent, excluding current portion | 1,434 | — |
Total long-term liabilities | 8,288 | 942 |
Total liabilities | 10,904 | 11,606 |
Stockholders' equity: | ||
Preferred Stock | — | — |
Common stock | 208 | 206 |
Additional paid-in capital | 120,651 | 118,043 |
Deficit accumulated during the development stage | (92,627) | (81,476) |
Total |
28,232 | 36,773 |
Total equity | 28,232 | 36,773 |
Commitments | — | — |
Total liabilities and equity |
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CONTACT:Source:Gordon Link Chief Financial Officer 515-598-2925 glink@linkp.com
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