NewLink Genetics Corporation Provides Operational Update and Reports First Quarter 2015 Financial Results
"In addition to working toward the second interim analysis of the IMPRESS clinical trial data, we drove the Company's other key clinical programs forward," said Dr.
HyperAcute® Cancer Immunotherapy Programs
NewLink Genetics'HyperAcute pancreatic cancer immunotherapy candidate in a Phase 3 clinical trial called, IMmunotherapy for Pancreatic RESectable cancer Study, or IMPRESS. The study, evaluating the addition of algenpantucel-L to standard of care therapy after surgery for pancreatic cancer, is fully enrolled and the second interim analysis is expected to be reported in the second quarter of 2015.
- 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 locally advanced pancreatic cancer. The Company continues to expect to complete enrollment in the second half of 2015.
Tergenpumatucel-L for patients with lung cancer is
NewLink Genetics'HyperAcute lung immunotherapy being tested in a randomized, Phase 2b study in advanced lung cancer. An update on this program will be provided in the second half of 2015.
- Dorgenmeltucel-L for patients with melanoma is being evaluated in a randomized Phase 2 study in combination with ipilimumab vs. ipilimumab alone.
IDO Pathway Inhibitor Program (Proprietary)
We expect to complete enrollment of the following studies with indoximod, our proprietary IDO pathway inhibitor, within the next 12-15 months.
- First is NLG2101, a global randomized Phase 2 trial testing indoximod in combination with docetaxel or paclitaxel in patients with metastatic breast cancer with full enrollment expected by the end of 2015.
Next is NLG2102, a Phase 1b/2 trial testing indoximod in combination with temozolomide in patients with progressive or refractory glioblastoma. We expect to report results from the Phase 1b portion at a poster presentation (#2070) during the
American Society of Clinical Oncologymeeting on Monday, June 1, 2015from 1:15 - 4:45 p.m. CT.
- Then there is NLG2103, a Phase 1b/2 trial testing indoximod in combination with ipilimumab in patients with advanced melanoma. We expect to report Phase 1b top-line results by the end of 2015; and
- Finally, we have NLG2104, a Phase 1b/2 trial testing indoximod in combination with gemcitabine plus nab-paclitaxel in patients with metastatic pancreas cancer. Phase 1b top-line results are expected in 2016.
Financial Results for the Three Month Period Ended
Cash Position: NewLink Genetics ended the quarter on
R&D Expenses: Research and development expenses in the first quarter of 2015 were
G&A Expenses: General and administrative expenses in the first quarter of 2015 were
"We finished the quarter 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. 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 31502548. 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:
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
Three Months Ended
|Grant revenue||$ 9,649||$ 334|
|Research and development||17,981||6,387|
|General and administrative||8,366||3,251|
|Income (loss) from operations||12,848||(9,304)|
|Other income (expense), net||11||68|
|Income (loss) before income taxes||12,859||(9,236)|
|Income tax expense||(1,669)||—|
|Net income (loss)||$ 11,190||$ (9,236)|
|Basic earnings per share||$ 0.40||$ (0.33)|
|Diluted earnings per share||$ 0.35||$ (0.33)|
|Basic average shares outstanding||28,218,631||27,605,910|
|Diluted average shares outstanding||31,919,318||27,605,910|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share data)|
|Cash, cash equivalents and certificates of deposit||$ 214,369||$ 202,797|
|Prepaid expenses, advance payments to vendors and other current assets||22,540||12,062|
|Income tax receivable||14,190||15,604|
|Total current assets||251,099||230,463|
|Property and equipment, net||8,028||7,599|
|Total assets||$ 259,127||$ 238,062|
|Liabilities and Equity|
|Accounts payable and accrued expenses||$ 13,408||$ 11,779|
|Other current liabilities||676||276|
|Total current liabilities||17,562||25,021|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||494||941|
|Unearned revenue, excluding current portion||1,024||1,085|
|Total long-term liabilities||8,734||9,264|
|Additional paid-in capital, net||254,966||236,838|
|Treasury stock, at cost||(491)||(222)|
|Total liabilities and equity||$ 259,127||$ 238,062|
CONTACT: Corporate Contact:
Jack HennemanChief Financial Officer, NewLink Genetics515-598-2561 Investor@linkp.com Investors: Donna LaVoieLaVoieHealthScience 617-374-8800, ext. 107 firstname.lastname@example.org Media: David ConnollyLaVoieHealthScience 617-374-8800, ext. 108 email@example.com
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