NewLink Genetics Corporation (NASDAQ:NLNK) Files An 8-K Regulation FD DisclosureItem 7.01.Regulation FD Disclosure.
NewLink Genetics Corporation, a Delaware corporation (the “Company”), expects to provide certain revised forward-looking guidance concerning its financial position and use of cash, and certain additional information concerning its Phase 2 clinical trial of indoximod in combination with PD-1 inhibitors for patients with advanced melanoma, at the Cantor Fitzgerald Global Healthcare Conference (the “Cantor conference”) on September 25, 2017. A copy of the Company’s presentation to be presented at the Cantor conference is available in the Investor Relations section of the Company’s website at www.newlinkgenetics.com. The revisions to the financial guidance include (i) a new forecast that the Company will have approximately $100 million in cash and cash equivalents on its balance sheet as of December 31, 2017, (ii) that the Company expects to use $14 – $16 million in cash from operations (excluding future financings and milestone or other payments from collaborators) on a quarterly basis for the foreseeable future, (iii) that the Company had sold approximately 1.9 million shares under its “at-the-market” offering after June 30, 2017, and (iv) that the Company estimates it has approximately two years of cash and equivalents as of the date hereof. The Company has approximately 31 million shares of common stock outstanding as of the date hereof.
The information in this Item 7.01 and in the presentation referenced herein shall not be deemed to be “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the presentation referenced herein shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Section8 – Other Events
Item 7.01.Other Events.
On September 25, 2017, the Company issued a press release titled "NewLink Genetics Announces Clinical Collaboration to Evaluate IO-Based Combination Therapies in Pancreatic Cancer."
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
This Current Report on Form 8-K contains forward-looking statements, including but not limited to, all statements about the Company’s revised financial guidance. Actual results could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements due to a number of important factors, including those risks discussed in “Risk Factors” and elsewhere in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 and other reports filed with the U.S. Securities and Exchange Commission. The forward-looking statements represent the Company’s views as of the date of this Current Report on Form 8-K. The Company undertakes no duty or obligation to update any forward-looking statements contained in this Current Report on Form 8-K as a result of new information, future events or changes in its expectations.
Section9 – Financial Statements and Exhibits
Item 7.01.FinancialStatements and Exhibits.
Press Release, dated September 25, 2017, entitled “NewLink Genetics Announces Clinical Collaboration to Evaluate IO-Based Combination Therapies in Pancreatic Cancer”
NEWLINK GENETICS CORP ExhibitEX-99.1 2 nlnk-20170925x8kxex991.htm PRESS RELEASE Exhibit Exhibit 99.1NewLink Genetics Announces Clinical Collaboration to Evaluate IO-Based Combination Therapies in Pancreatic CancerPhase 2,…To view the full exhibit click
About NewLink Genetics Corporation (NASDAQ:NLNK)
NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing immunotherapeutic products for cancer treatment. The Company’s portfolio includes biologic and small-molecule immunotherapy product candidates for a range of oncology indications. Its biologic product candidates are based on its HyperAcute immunotherapy technology platform, which is designed to stimulate the human immune system. Algenpantucel-L is its clinically advanced product candidate for patients with pancreatic cancer. Its additional HyperAcute cellular HyperAcute Cellular Immunotherapy product candidates in clinical development include tergenpumatucel-L and dorgenmeltucel-L for patients with advanced lung cancer and melanoma. It has two small-molecule product candidates in clinical development: GDC-0919 and indoximod. These product candidates are indoleamine-2, 3-dioxygenase (IDO) pathway inhibitors and focus on breaking the immune system’s tolerance to cancer.