NewLink Genetics Provides Operational Update and Reports Fourth Quarter, Year End 2015 Financial Results
NewLink Genetics Outlines 2016 Business Priorities to
Management to Host Conference Call and Webcast Today at
"During 2015, we made advances across multiple immuno-oncology clinical programs," said
- Reported continued progress of the pivotal, Phase 3 IMmunotherapy for Pancreatic RESectable cancer Study (IMPRESS) trial of algenpantucel-L, for patients with resected pancreatic cancer.
- Attracted top biotechnology
talent to support increasing manufacturing capacities, the pre-commercialization efforts related to algenpantucel-L, and the expansion of clinical trial programs.
- Completed enrollment in the Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced Non-Resectable Cancer (PILLAR) trial of algenpantucel-L for patients with locally advanced pancreatic cancer.
- Presented Phase 1b/2 clinical data of indoximod in combination with temozolomide for patients with refractory malignant brain tumors at the
Society of Neuro-Oncology Meeting, demonstrating evidence of clinical activity.
- Completed enrollment in a randomized, Phase 2 trial with indoximod for patients with metastatic breast cancer and presented preliminary safety data at the
San Antonio Breast Cancer Symposium.
- Presented with
Genentech, a member of the Roche Group, results from a Phase 1 study of GDC-0919 at ESMO/ECC. In addition, a Phase 1b, open-label, dose-escalation study of the safety and pharmacology of GDC-0919 in combination with atezolizumab for patients with advanced solid tumors began enrollment.
- Added additional commercial oncology and clinical expertise to the board with the appointment of Mr.
Paolo Pucciand Dr. Nicholas Vahanian.
- Analysis of interim data from a Phase 3 ring vaccination trial in
Guineawas published in the July 31st issue of The Lancet. NewLink Geneticswas awarded an additional $30.5 millionin government funding to support the scale-up of manufacturing for the Ebola vaccine candidate, rVSV-ZEBOV, and other vaccine development initiatives.
- Finished 2015 with
$197.8 millionin cash and equivalents.
"In 2016, we anticipate significant progress toward milestones in our HyperAcute® Cellular Immunotherapy and IDO pathway inhibitor programs," said
Anticipated Highlights in 2016
- Top-line results of the pivotal, Phase 3 registration IMPRESS study for patients with resected pancreatic cancer expected this year.
- Update on the timing of results in the PILLAR study for patients with locally advanced pancreatic cancer.
- Report on additional clinical progress from the proprietary indoximod program in multiple indications in the following Phase 2 trials:
- Indoximod and gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer.
- Indoximod and ipilimumab or PD-1 inhibitors for patients with metastatic melanoma.
- Indoximod and temozolomide for patients with refractory malignant brain tumors.
- Indoximod and docetaxel or paclitaxel for
patients with metastatic breast cancer.
- Accelerate enrollment in a triple combination trial of tergenpumatucel-L, indoximod and docetaxel for patients with advanced non-small cell lung cancer.
- Update on the clinical progress of GDC-0919 combinations for patients with solid tumors by
- Update on progress and funding for the Zika vaccine program.
"The investments we made in 2015 advanced our pipeline of drug candidates, expanded our manufacturing capacity, and developed our pre-commercial sales and marketing infrastructure," said
Cash Position: NewLink Genetics ended the year on December 31, 2015, with cash, cash equivalents, and certificates of deposit totaling $197.8 million compared to $202.8 million for the year ending December 31, 2014. The decrease was attributable primarily due to the increased expenses for R&D and pre-commercialization development, offset by amounts received under government contracts and the
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2015 were
Net Income/Loss: NewLink Genetics reported a net loss of $21.6 million or a
NewLink Genetics ended 2015 with 28,814,142 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the results and to give an update on clinical and business development activities. NewLink Genetics' senior management team will host the 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 conference call is available by dialing (855) 469-0612 (
HyperAcute® Cellular Immunotherapies
A unique, tumor-specific product candidates that take advantage of a pre-existing human immune response to initiate a powerful cascade, potentially educating the body's natural defenses to identify and destroy cancer cells. Unlike other immuno-oncology products, HyperAcute® Cellular Immunotherapies do not require patient tissue or cancer cells and are designed to be easy to administer. HyperAcute® Cellular Immunotherapies use allogeneic (disease-specific, not patient-specific), tumor-specific human cell lines that have been modified to express alpha-gal. Intact, whole cells are used rather than cell fragments or purified proteins, which we believe results in the stimulation of a more powerful immune response. The company's most advanced clinical program utilizing this technology is for patients with pancreatic cancer. Additionally, there are on-going clinical development programs and data on induced immune responses targeting non-small-cell lung cancer, melanoma, prostate cancer and renal cancer.
Indoleamine 2,3-Dioxygenase (IDO) Checkpoint Inhibitors
The indoleamine 2,3-dioxygenase (IDO) pathway regulates immune response by suppressing T cell function and enabling local
tumor immune escape.
Ebola Vaccine Program with Merck
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and such statements are subject to the "safe harbor" created by those sections. Forward-looking statements involve substantial risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would,"
"could," "should," "continue," "contemplate," 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. The forward-looking statements in this press release include, among other things, statements regarding the following: NewLink Genetics' financial guidance for 2016; enrollment in or results of its clinical trials for product candidates; its timing of release of data from ongoing clinical studies; its plans related to moving additional indications into clinical development; NewLink Genetics' 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. The forward-looking statements in this press release represent
NewLink Genetics' views as of the date of this press release. Although
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended ||Year Ended |
|Licensing and collaboration revenue||1,588||165,950||36,143||165,950|
|Research and development||14,795||11,933||71,414||35,691|
|General and administrative||7,682||8,283||30,689||19,328|
|Income (loss) from operations||(14,825||)||149,029||(33,602||)||117,573|
|Other income (expense), net||(11||)||15||(41||)||60|
|Net (loss) income before taxes||(14,836||)||149,044||(33,643||)||117,633|
|Income tax expense||(6,738||)||(29,029||)||(6,738||)||(21,616||)|
|Net (loss) income||$||(21,574||)||$||120,015||$||(40,381||)||$||96,017|
|Basic (loss) earnings per share||$||(0.75||)||$||4.29||$||(1.41||)||$||3.45|
|Diluted (loss) earnings per share||$||(0.75||)||$||3.83||$||(1.41||)||$||3.09|
|Basic average shares outstanding||28,788,615||27,965,055||28,586,585||27,838,873|
|Diluted average shares outstanding||28,788,615||31,345,654||28,586,585||31,025,099|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and certificates of deposit||$||197,800||$||202,797|
|Prepaid expenses and other current assets||10,342||12,062|
|Income tax receivable||—||8,763|
|Total current assets||208,142||223,622|
|Property and equipment, net||10,400||7,599|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||12,422||$||11,779|
|Other current liabilities||667||276|
|Income taxes payable||859||—|
|Total current liabilities||14,840||25,021|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||368||941|
|Unearned revenue, excluding current portion||407||1,085|
|Total long-term liabilities||7,928||9,264|
|Additional paid-in capital, net||276,610||236,838|
|Total liabilities and equity||$||218,542||$||231,221|
Jack HennemanChief Financial Officer (515) 598-2561 Investor@linkp.com Investor Contact: Donna LaVoieor Rachel GirardLaVoieHealthScience 617-374-8800, ext. 107/102 email@example.com firstname.lastname@example.org Media: David ConnollyLaVoieHealthScience 617-374-8800, ext. 108 email@example.com
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