Why NewLink Genetics Corp. Shares Spiked Higher

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of NewLink Genetics (NASDAQ: NLNK  ) , a clinical-stage biopharmaceutical company focused on developing immunotherapeutic products for the treatment of cancer, spiked higher by as much as 14% after announcing positive phase 2 data utilizing dorgenmeltucel-L and pegylated interferon-alpha 2b in patients with advanced metastatic melanoma.

So what: According to NewLink's press release, its once-weekly injectable drug (for 12 weeks) plus pegylated interferion (from weeks 5 through 12) produced 21 evaluable patients out of 25 enrollees. Of the 16 stage 4 disease patients enrolled, two has a complete RECIST response, one had stable disease, and four had no evidence of disease. Of the remaining nine patients that were stage 2/3, three had no evidence of disease, while one stage 2C patients had slow progressive disease. As noted, 60% of patients survived longer than a year with the median overall survival of the study being 29 months. Dorgenmeltucel-L was also shown to be safe and tolerable in its study. In addition to its positive phase 2 study, NewLink launched an additional melanoma trial utilizing dorgenmeltucel-L and ipilimumab which will test dorgenmeltucel-L in a higher dose concentration to determine if it will help metastatic melanoma patients live longer.

Now what: Cancer immunotherapies remain a hot topic discussion among biotech investors, even if these stocks have given up most, or in NewLink's case all of their 2014 gains. NewLink is developing quite an extensive pipeline of therapies meant to stimulate a patient's immune system in the hope that it will attack targeted cancer cells. The early indications from all of its studies are that its methods are working. Of course, keep in mind there's still plenty of risk here as we're dealing with a wholly clinical-stage company that's burning through large amounts of cash to conduct these extensive trials which often take years. Perhaps the best way to put it is I'm cautiously optimistic of NewLink Genetics going forward, but I would suggest only risk-willing and biotech-savvy investors with a taste for volatility consider digging deeper into this company.

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  • Report this Comment On May 31, 2014, at 7:02 AM, entheogenius wrote:

    Yes I have some interference interfearons .

    Hi Francis McLaughlin,

    This is Brian Harris, case # 1441532, remember when you and a coworker coerced me into false imprisonment at Regions hospital after lying to me about being able to have a functional MRI and a sleep study done? I sure do.

    While Greg Feigum was falsifying my statement to trivialize me and make me sound delusional, you photocopied my 2 journals and chewed your fingertips raw in the process. Put some gloves on. They are now about to be published with the rest of my book.

    So Electronic Stalking is now a Federal Crime and my theoretical cure for cancer that was in those journals and used as proof of my grandiose delusional system is now called a miracle cancer cure by the Mayo Clinic. So I'm a nut huh? I just saw another one of my ideas from those notebooks Fran, one for yeast cells genetically modified to turn sugar into essential oils for perfume last week. It is now being used to make Patchouli oil. In my file, the first page of those photocopied journals has a post it note saying "Well Fran, Brian Harris is certainly prolific!" Who wrote that Fran? They owe me a stolen Cancer cure and 100's of millions of dollars worth of Patchouli oil.

    I was refused both test's by Dr. Thomas Gratzer on the basis he could find no criterion to do so because I'm supposedly a schizophrenic. Telling him the only reason he was refusing me those tests and forcing me on medication was to feed his ego became the basis for 8 months false imprisonment as well as stating that being a Scientologist makes it illegal to medicate me because it violates my right to practice freedom of religion and if you force it on me I will sue, while calmly lying in bed to a student nurse, was now called verbally inappropriate, threatening behavior and laying in bed saying no was physical intimidation. Yeah right. You all sold me out.

    Minnesota psychiatrists sold my notebooks, the ones I wrote as proof of date of conception while false imprisoned as mentally ill. Psychiatrists are thieves who will always label a genius as mentally ill, and rob them blind while holding them captive.

  • Report this Comment On May 31, 2014, at 7:12 AM, entheogenius wrote:

    What all of those greedy, lying stealing psychopaths didn't realize what they stole from me is like ripping off nuclear launch codes and thinking they could profit. I kept my secrets for a reason and only divulged them because I was in mortal danger. Yeast cells that can turn sugar into any drug made by a genetic code.7-12-07

    I just got a loud ringing in my left ear. Digital tinnitus gets old real fast. The brethren said they want to steal all of my ideas (not like they already haven't) so I'm going to write them down as proof of date of conception. Many of my ideas are for genetic recombinant yeasts.

    7-13-07

    Yeast cells can be genetically modified to produce virtually any compound found in any animal or plant. R-insulin is human insulin made by a bacterium that was genetically modified to do so. Before this diabetics had to use insulin extracted from animal tissues.

    R-BGH & R-BST are bovine (cow) hormones made from a r- recombinant bacteria that were modified to make cow hormones. As I understand most recombinant compound are produced by bacteria. My plan is to use yeast cells because I'm a wine brewer. My ideas include:

    R-opiates

    R-cocaine

    R-pseudoephedrine

    Those first 3 and an ethanol plant and maybe an E-85 mandate could make me the biggest drug kingpin ever. Nudge nudge wink wink. My plan though was to sell it to the pharmaceutical industries.

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12/19/2014 3:59 PM
NLNK $40.11 Up +2.90 +7.79%
NewLink Genetics C… CAPS Rating: **

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