NewLink Genetics Corporation Provides Operational Update and Reports Third Quarter 2015 Financial Results
"Our dynamic and experienced team has made significant progress in driving our broad clinical development programs," said
"As we anticipate the data readout for the IMPRESS trial in 2016,
Financial Results for the Three-Month Period Ended
R&D Expenses: Research and development expenses in the third quarter of 2015 were
G&A Expenses: General and administrative expenses in the third quarter of 2015 were
Conference Call and Program Updates:
has scheduled a conference call for
IDO Checkpoint Inhibitor Programs
NewLink Genetics entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of the IDO checkpoint inhibitor GDC-0919 and an expanded pipeline of potential IDO/TDO inhibitor candidates in 2014. This product candidate is currently in Phase 1 clinical development for patients with advanced solid tumors.
- Key preclinical data is being presented at the
Society for Immunotherapy of Cancer(SITC) Annual Meeting in Bethesda, Marylandon November 6, 2015.
- Phase 1 data on GDC-0919 was presented at the ECC/ESMO meeting in
Vienna. Key preliminary data showed that GDC-0919 had a favorable safety profile and preliminary evidence of disease stabilization and peripheral pharmacodynamic modulation. Details from the poster presentation are available in the press release found at http://investors.linkp.com/releasedetail.cfm?ReleaseID=933270
- The collaboration's clinical development team has advanced GDC-0919 into a combination study with atezolizumab that is actively enrolling patients. In addition, the collaboration is planning combination studies
of GDC-0919 with OX-40 agonists.
- NewLink will be eligible to receive in excess of
$1 billionin milestone payments based on achievement of certain predetermined milestones as well as escalating double-digit royalties on potential commercial sales of multiple products by Genentech.
HyperAcute® Cellular Immunotherapy Programs
NewLink Genetics' proprietary HyperAcute Cellular 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 Cellular Immunotherapy product candidate for patients with pancreatic cancer. The product is currently being studied in a Phase 3 clinical trial called IMPRESS, or IMmunotherapy for Pancreatic RESectable Cancer Study, in patients with surgically resected pancreatic cancer. The study is powered to show an improvement in overall survival after 442 events, and we continue to expect that final results will be reported in 2016.
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 for patients with borderline resectable or locally advanced unresectable pancreatic cancer. We expect to complete enrollment in this study in 2015.
Tergenpumatucel-L, NewLink Genetics' HyperAcute Cellular Immunotherapy product candidate for patients with non-small cell lung cancer (NSCLC), remains in Phase 2. We are eager to learn more about this product in our recently begun trial evaluating tergenpumatucel-L in combination with indoximod and chemotherapy for patients with advanced NSCLC.
Dorgenmeltucel-L, NewLink Genetics' HyperAcute Cellular Immunotherapy product candidate for patients with melanoma, continues in a trial evaluating efficacy in combination with the checkpoint inhibitors ipilimumab, nivolumab, and pembrolizumab for patients with advanced melanoma.
During the third quarter, we announced that
NewLink has exclusively licensed research, development, manufacturing and commercialization of the rVSV-ZEBOV (Ebola) vaccine to
Conference call details
NewLink Genetics' 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. 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 66888213. The replay will be available for two weeks from the date of the call.
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 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 ||Nine Months Ended |
|Licensing and collaboration revenue||844||—||34,555||—|
|Research and development||22,508||10,896||56,619||23,760|
|General and administrative||7,384||4,931||23,007||11,044|
|Loss from operations||(15,683||)||(13,026||)||(18,777||)||(31,457||)|
|Other income (expense), net||(63||)||15||(30||)||47|
|Loss before income taxes||(15,746||)||(13,011||)||(18,807||)||(31,410||)|
|Income tax (expense) benefit||(160||)||7,413||—||7,413|
|Basic and diluted loss per share||$||(0.55||)||$||(0.20||)||$||(0.66||)||$||(0.86||)|
|Basic and diluted average shares outstanding||28,734,768||27,914,782||28,518,503||27,800,246|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and certificates of deposit||$||200,357||$||202,797|
|Prepaid expenses, advance payments to vendors and other current assets||16,758||12,062|
|Income tax receivable||76||8,775|
|Total current assets||217,191||223,634|
|Property and equipment, net||9,628||7,599|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||9,649||$||11,779|
|Other current liabilities||665||276|
|Total current liabilities||11,215||25,021|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||409||941|
|Unearned revenue, excluding current portion||608||1,085|
|Total long-term liabilities||8,192||9,264|
|Additional paid-in capital, net||266,454||236,838|
|Total liabilities and equity||$||226,819||$||231,233|
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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