NewLink Genetics Corporation Provides Operational Update and Reports Fourth Quarter and Year End 2014 Financial Results
"2014 was a pivotal year for our company, and we advanced significantly across all areas of our business and most importantly toward our goal to bring new cancer therapies to patients," said
"Also, in 2014, we partnered our IDO inhibitor platform with
HyperAcute® Cancer Immunotherapy Programs
Algenpantucel-L for Patients with Pancreatic Cancer
The Phase 3 pivotal trial, known as IMPRESS, is designed to study standard adjuvant therapy alone or in combination with algenpantucel-L in patients who have undergone surgical resection for pancreatic cancer. This study is fully enrolled, and the first interim analysis previously has been reported.
The Company revised its timing expectations and stated today that it expects to report on the second interim analysis in the first or second quarter of 2015. The possible outcomes for the second interim look include confirmation of continuing the study as designed to the pre-planned endpoint. The alternative outcome is a decision to proceed with filing with the
FDAon the basis of the interim data due to improvement in overall survival rate as determined by the early stopping rules in the trial's Special Protocol Assessment.
The Phase 3 pivotal trial, known as Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable disease or PILLAR is currently enrolling patients.
The Company reported that it expects to complete enrollment in the second half of 2015. When enrollment is completed,
NewLink Geneticswill provide guidance on the reporting of the preliminary results.
Tergenpumatucel-L for Patients with Advanced Lung Cancer
IDO/TDO Pathway Inhibitor Programs
Since announcing this alliance,
NewLink Geneticsand Genentechhave launched both preclinical drug discovery and clinical development teams, which are already hard at work on the collaboration.
- In addition, the Company confirmed that it will continue the development of indoximod, including studies in combination with HyperAcute product candidates. The Company expects to complete enrollment of four different oncology trials by the first half of 2016.
Ebola Vaccine Program with Merck
In addition to the
The Company is currently collaborating with the Public Health Agency of
Canada, the National Institutes of Health, the Center for Disease Control, the United States Department of Defense, and multiple international agencies and is conducting multiple clinical trials around the world.
In 2014, the Company announced that it received significant funding from the
Department of Defenseand the Biomedical Advanced Research and Development Authorityto support the manufacturing of the vaccine at various dose levels as well as early clinical trials and important groundwork needed to move the candidate to effectiveness trials.
Thomas P. Monath, a top vaccine expert was hired to lead NewLink Genetics'infectious disease effort and is building its organization in the Bostonarea to support this important initiative.
R&D Expenses: Research and development expenses in the fourth quarter of 2014 were
G&A Expenses: General and administrative expenses in the fourth quarter of 2014 were
"We finished the year with a strong cash position and the capacity to make the necessary investments to become a commercial biopharmaceutical company," said
The Company has scheduled a conference call for
NewLink's senior management team will host the conference call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.
Access to the live call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The call can also be accessed through a webcast via a link provided on the Investors and Media homepage of NewLink's website at www.NewLinkGenetics.com. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 88421787. The replay will be available for two weeks from the date of the call, and the webcast will also be archived on the website.
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:
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
Three Months Ended
|Grant revenue||$ 3,295||$ 294||$ 6,642||$ 1,093|
|Research and development||11,931||5,208||35,691||22,713|
|General and administrative||8,284||2,999||19,328||9,521|
|Income (loss) from operations||149,030||(7,913)||117,573||(31,141)|
|Other income (expense), net||13||(3)||60||91|
|Income (loss) before income taxes||149,043||(7,916)||117,633||(31,050)|
|Income tax expense||(22,188)||(130)||(14,775)||(130)|
|Net income (loss)||$ 126,855||
|Basic earnings per share||$ 4.54||
|Diluted earnings per share||$ 4.05||
|Basic average shares outstanding||27,956,055||25,890,638||27,838,873||25,275,179|
|Diluted average shares outstanding||31,345,654||25,890,638||31,025,099||25,275,179|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share data)|
|Cash, cash equivalents and certificates of deposit||$ 202,797||$ 61,540|
|Prepaid expenses, advance payments to vendors and other current assets||12,062||2,430|
|Income tax receivable||15,604||—|
|Total current assets||230,463||63,970|
|Property and equipment, net||7,599||6,587|
|Total assets||$ 238,062||$ 70,557|
|Liabilities and Equity|
|Accounts payable and accrued expenses||$ 11,779||$ 3,473|
|Other current liabilities||357||403|
|Total current liabilities||25,102||3,876|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||860||1,033|
|Unearned revenue, excluding current portion||1,085||—|
|Total long-term liabilities||9,183||8,354|
|Additional paid-in capital, net||236,838||194,038|
|Treasury stock, at cost||(222)||—|
|Total liabilities and equity||$ 238,062||$ 70,557|
CONTACT: Corporate Contact:
Jack HennemanChief Financial Officer, NewLink Genetics515-598-2561 Investor@linkp.com Investors: Donna LaVoieLaVoieHealthScience 617-374-8800, ext. 107 email@example.com Media: David ConnollyLaVoieHealthScience 617-374-8800, ext. 108 firstname.lastname@example.org
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