NewLink Genetics Corporation Provides Operational Update and Reports Second Quarter 2015 Financial Results
"NewLink Genetics continues to drive forward, and to execute on, its strategy of developing treatment options for patients with cancer using targeted immune response and disruptive checkpoint blockade," said Dr.
"During the second quarter, we continued our planned hiring and pre-commercial activities relating to our HyperAcute Immunotherapy algenpantucel-L, which is being studied for adjuvant treatment of patients
with surgically resected pancreatic cancer," said Dr.
The Company continued to build its presence with key opinion leaders by having a booth and poster presentation at the
In addition, the Company hosted its first-ever analyst day on
HyperAcute® Immunotherapy Cancer Programs
NewLink Genetics' proprietary HyperAcute Immunotherapy programs may prove to have broad potential for patients across a spectrum of cancer indications, including use in combination with checkpoint inhibitors.
- Algenpantucel-L is NewLink Genetics' HyperAcute Immunotherapy pancreatic cancer candidate in a Phase 3 clinical trial called IMPRESS, or IMmunotherapy for Pancreatic RESsectable Cancer Study. During the second quarter, following the second interim analysis of the study, the Company announced the recommendation of the data safety monitoring committee to proceed without modification to final analysis. The Company has announced that at the time of the second interim analysis, the estimated blended median overall survival in the trial from the time of randomization was 28.5 months for all patients. Median time from surgery to randomization was approximately 1.5 months. Therefore median survival from surgery was estimated to be approximately 30 months
for all patients in our study. We believe that the median months of overall survival from randomization in the control arm is in the low twenties. The study is powered to show an improvement in overall survival after 442 events.
- PILLAR, or Pancreatic Immunotherapy with Algenpantucel-L for Locally Advanced Non-Resectable Disease, is our Phase 3 clinical trial studying the efficacy of algenpantucel-L in patients with borderline resectable or locally advanced pancreatic cancer. We expect to complete enrollment in this study during 2015.
- NewLink Genetics' HyperAcute Immunotherapy product candidate tergenpumatucel-L is being tested versus docetaxel in a randomized Phase 2b study in patients with advanced lung cancer. We are currently enrolling patients in this
- HyperAcute Immunotherapy product candidate dorgenmeltucel-L for patients with melanoma is being evaluated in a randomized Phase 2 study in combination with the checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab versus these checkpoint inhibitors alone.
IDO Pathway Inhibitor Programs
- NLG2101, a global randomized Phase 2 trial testing indoximod in combination with docetaxel or paclitaxel in patients with metastatic breast
cancer, is expected to fully enroll by the end of 2015.
NewLink Geneticsintends to present preliminary data from this study at an upcoming medical meeting in 2015.
- NLG2102 is a Phase 2 trial of the combination of indoximod and temozolomide in refractory or relapsed glioblastoma multiforme patients.
- NLG2103 is a Phase 2 trial testing indoximod in combination with the checkpoint inhibitors ipilimumab, nivolumab or pembrolizumab in patients with advanced melanoma. We expect to report top-line Phase 1b results at the Immunotherapy in Cancer Poster Session of the ESMO/ECC meeting in
Viennaon Saturday, September 26(#248, abstract 514).
- NLG2104 is in a Phase 1b/2 trial testing indoximod in combination with gemcitabine
plus nab-paclitaxel in patients with metastatic pancreatic cancer. Top-line Phase 1b results are expected in 2016.
NewLink Genetics has also entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of the IDO inhibitor GDC-0919. Based on pre-clinical data presented at ASCO by our partner, GDC-0919 demonstrated decreases in plasma kynurenine levels and regulatory T-cells as well as an anti-tumor efficacy when combined with anti-PD-L1 and anti-CTLA4. This product candidate is currently in Phase 1 clinical development in patients with advanced solid tumors, and Phase 1 data on GDC-0919 is expected to be presented in a poster presentation at the ESMO/ECC meeting in
Financial Results for the Three-Month Period Ended
R&D Expenses: Research and development expenses in the second quarter of 2015 were
"Our research and development expenses and capital expenditures continue to reflect our commitment to developing a broad pipeline of drug candidates and to ensure that we have the infrastructure in place to support the commercialization and manufacturing of algenpantucel-L," said
The Company has scheduled a
conference call for
Cautionary Note Regarding Forward-Looking Statements
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 Genetics' financial guidance for 2015; 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. 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 Genetics' Annual Report on Form 10-K for the year ended
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended ||Six Months Ended |
|Licensing and collaboration revenue||4,165||—||33,711||—|
|Research and development||16,130||6,475||34,111||12,863|
|General and administrative||7,257||2,863||15,623||6,114|
|Loss from operations||(15,942||)||(9,126||)||(3,094||)||(18,431||)|
|Other income (expense), net||22||(38||)||33||32|
|Loss before income taxes||(15,920||)||(9,164||)||(3,061||)||(18,399||)|
|Income tax benefit||1,829||—||160||—|
|Basic and diluted loss per share||$||(0.49||)||$||(0.33||)||$||(0.10||)||$||(0.66||)|
|Basic and diluted average shares outstanding||28,661,588||27,876,652||28,408,474||27,742,029|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share data)|
|Cash, cash equivalents and certificates of deposit||$||207,579||$||202,797|
|Prepaid expenses, advance payments to vendors and other current assets||24,354||12,062|
|Income tax receivable||2,519||15,604|
|Total current assets||234,452||230,463|
|Property and equipment, net||8,798||7,599|
|Liabilities and Equity|
|Accounts payable and accrued expenses||$||7,428||$||11,779|
|Other current liabilities||672||276|
|Total current liabilities||9,036||25,021|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||450||941|
|Unearned revenue, excluding current portion||809||1,085|
|Total long-term liabilities||8,455||9,264|
|Additional paid-in capital, net||262,055||236,838|
|Treasury stock, at cost||(551||)||(222||)|
|Total liabilities and equity||$||243,250||$||238,062|
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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