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Newlink Genetics Corp (NLNK) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

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Newlink Genetics Corp

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CIK: 1126234 Ticker: NLNK
Exhibit 99.1


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FOR IMMEDIATE RELEASE

NewLink Genetics Reports Fourth Quarter, Year-End 2018 Financial Results and Provides Update for Clinical Programs
- Management to Host Conference Call Today at 4:30 p.m. ET
Ames, Iowa, February 27, 2019 -- NewLink Genetics Corporation (NASDAQ:NLNK) today reported consolidated financial results for the fourth quarter and year ended 2018, as well as progress in its clinical development programs. The Company also outlined key 2019 priorities related to its clinical pipeline.
“In 2018, we published further clinical results on indoximod that suggest it has significant activity in combination therapy for a variety of cancer indications,” said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. “As we enter 2019 with a strong cash position, our intention is to focus on developing the best potential registration strategy for bringing indoximod forward and further developing our pipeline assets, especially NLG207. We would like to thank the investigators and patients who support our clinical trials year after year, and we remain committed to your care.”
Anticipated 2019 Outlook
•
Updated results on the cohort of patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), from the efficacy portion of a Phase 1b study of indoximod for the treatment of pediatric patients with recurrent malignant brain tumors, are anticipated in 2019
•
Results from a Phase 2 study of NLG207 (formerly CRLX101), a nanoparticle formulation of the topoisomerase 1 inhibitor, camptothecin, conducted by the Gynecological Oncology Group (GOG) for patients with recurrent ovarian cancer, has been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019, at the Georgia World Conference Center, in Atlanta, March 29 - April 3, 2019
•
Updated results from a Phase 1 study of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, are anticipated in 2019
•
Updated results from a Phase 1b study of indoximod for pediatric patients with recurrent malignant brain tumors are anticipated in 2019
•
Completion by Merck of the rolling Biologics License Application (BLA) filing for V920 (rVSV∆G-ZEBOV-GP), our partnered Ebola vaccine candidate, is expected in 2019
2018 Highlights
•
Presented Phase 1 results of indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed DIPG at the American Association of Clinical Research (AACR) Annual Meeting, April 2018, and updated Phase 1 results at the International Symposium of Pediatric Neuro-Oncology (ISPNO) Annual Meeting, July 2018, showing symptomatic improvement and marked radiographic improvement in DIPG patients.


The following information was filed by Newlink Genetics Corp (NLNK) on Wednesday, February 27, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Newlink Genetics Corp's 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parentheticals)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Equity
Consolidated Statements Of Equity (Parentheticals)
Consolidated Statements Of Operations
Commitments And Contingencies
Common Stock Equity Incentive Plans
Common Stock Equity Incentive Plans (Authorized Increases Of Common Stock) (Details)
Common Stock Equity Incentive Plans (Intrinsic Value Of Options Exercised) (Details)
Common Stock Equity Incentive Plans (Narrative) (Details)
Common Stock Equity Incentive Plans (Range Of Assumptions Used) (Details)
Common Stock Equity Incentive Plans (Restricted Stock Activity) (Details)
Common Stock Equity Incentive Plans (Stock Option Activity) (Details)
Common Stock Equity Incentive Plans (Tables)
Description Of Business Activities
Description Of Business Activities (Details)
Employee Benefit Plans
Employee Benefit Plans (Details)
Income Taxes
Income Taxes (Tables)
Income Taxes Deferred Tax (Details)
Income Taxes Income Tax Expense (Details)
Income Taxes Income Tax Rate Reconciliation (Details)
Income Taxes Narrative (Details)
Income Taxes Uncertain Income Tax Positions (Details)
Leasehold Improvements And Equipment
Leasehold Improvements And Equipment (Details)
Leasehold Improvements And Equipment (Tables)
Leases
Leases (Details)
Leases (Tables)
License And Research Collaboration Agreements
License And Research Collaboration Agreements (Details)
Licensing Agreements
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Licensing Agreements (Tables)
Long-Term Debt Conversion To Royalty Obligation
Long-Term Debt Conversion To Royalty Obligation (Details)
Loss Per Share
Loss Per Share (Antidilutive Securities) (Details)
Loss Per Share (Net Loss Per Share Computation) (Details)
Loss Per Share (Tables)
Quarterly Financial Information (Unaudited)
Quarterly Financial Information (Unaudited) (Details)
Quarterly Financial Information (Unaudited) (Tables)
Restructuring Charges
Restructuring Charges (Details)
Restructuring Charges (Tables)
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Revenues (Effects Of New Accounting Pronouncements) (Details)
Revenues (Tables)
Significant Accounting Policies
Significant Accounting Policies (Details)
Significant Accounting Policies (Policies)
Stockholders' Equity
Stockholders' Equity (Details)
Ticker: NLNK
CIK: 1126234
Form Type: 10-K Annual Report
Accession Number: 0001126234-19-000026
Submitted to the SEC: Tue Mar 05 2019 10:58:50 AM EST
Accepted by the SEC: Tue Mar 05 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations

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