Geron Corporation: Time to Panic?

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Shares of Geron  (NASDAQ: GERN  ) fell over 15% on Monday and, at first glance, the problem appeared to be the company's 8-K. In that filing, the company disclosing that 25% of patients enrolled in an early stage trial for Geron's experimental treatment for myelofibrosis, called imetelstat, dropped out. Put simply, the concern is that the dropout rate is so high because imetelstat is ineffective, or the side-effects are potentially too burdensome for some patients to handle.

But I'm not sure either scenario tells the full story. Instead, it looks like investors may have prematurely hit the eject button. To understand my view, we need to dig deeper into yesterday's trading in the health care sector, imetelstat's clinical history, and consider the dropout rates for similar types of drugs.

Biopharmas got walloped Monday
First off, it would be easy to pin the blame for Geron's massive decline squarely on the 8-K, but that would negate the downtrend in the health care sector as a whole. Despite Geron's decline Monday, it didn't even take the top spot among small caps in terms of losses. That dubious honor goes to Cell Therapeutics, which fell over 16% on heavy volume.

Most telling is the fact that Cell Therapeutics fell without a material event to blame, and this was the case for several other biopharmas as well. In a weird twist of fate, Cellular Therapeutics even received a major upgrade from Roth Capital just last week, further suggesting that small cap biopharmas are facing downward pressure in general. Keeping with this idea, the entire health care sector fell by 2.59%  Monday, showing that Geron wasn't the only stock to drop in this space.

Investors are probably skittish over imetelstat's clinical history
Although imetelstat is showing impressive results in early stage trials as a potential treatment for hematologic malignancies, the drug has a history of failing as a cancer treatment in mid-stage trials. Back in 2012, Geron performed unplanned interim analyses for imetelstat as a treatment for both breast and lung cancer, after which the drug's development was discontinued in both indications. Put simply, imetelstat failed to outperform the current standards of care for these diseases, despite showing promise in early stage trials.

So, my take is that investors are worried that history may repeat itself. According to Monday's 8-K, Geron is planning to push imetelstat into a mid-stage for myelofibrosis, so we'll know the answer sooner than later. Nonetheless, I think the high discontinuation rate in the current trial stoked some of these fears, adding to the intensity of yesterday's sell-off.

Is a 25% dropout rate normal for clinical trials?
When looking across the broad spectrum of clinical trials, a recent study showed that a 20% or greater dropout rate occurs around 18% of the time. What's important to understand is that dropout rates tend to increase with the severity of the disease, in part because the treatments are more toxic, or the disease is progressing to the point where treatment is no longer viable.

Because myelofibrosis can cause debilitating symptoms that are life-threatening and imetelstat does have nasty side effects, it's entirely possible that a fair number of patients simply decided to discontinue treatment, feeling the risk to reward ratio wasn't beneficial. But what is important to understand is that this dropout rate isn't abnormal for life-threatening diseases like myelofibrosis.

If we look at Incyte's approved therapy for myelofibrosis called Jakafi, an interesting similarity arises. Specifically, Jakafi's developers reported that 24% of patients receiving the drug dropped out of early stage clinical trials within a year, and this rate climbed to 46% after thirty-two months. Viewed this way, I don't see imetelstat's 25% dropout rate as anything to panic over.

Foolish final thoughts
Geron is a highly speculative play in the biopharma sector, and it will undoubtedly be a volatile stock going forward. That said, I view this week's plunge as a conglomeration of a sector wide sell-off, fears over the drug's past failures, and a general overreaction to a dropout rate that wasn't given any context in the 8-K filing. None of these factors should change the current investment thesis for Geron, but don't expect smooth sailing head. Investors who aren't into wild swings in share price should probably look elsewhere during this turbulent time.

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Read/Post Comments (4) | Recommend This Article (1)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On January 30, 2014, at 6:47 PM, johnson12345 wrote:

    Seriously, Another fool who didn't do his homework. If you read the current prospectus, you see that the discontinuation rate actually has DROPPED. In the first 33 patients, 9 discontinued and later is was indicated that 5 more dropped out mostly due to severity of disease. That is 14 patients out of the first 33. Then as indicated later, 79 total have enrolled- or an additional 46 and we have 20 who have discontinued (20 of 79, hence the author's 25%), that means ONLY 6 of 46 have discontinued since the original 33!. That is a MONSTROUS IMPROVEMENT. Probably part of the reason for significant rally today.

  • Report this Comment On January 30, 2014, at 9:11 PM, eecar57 wrote:

    Anybody want to try explaining how GERN closed up a dollar when the company priced a secondary at $4.00?

  • Report this Comment On January 30, 2014, at 10:05 PM, leviek wrote:

    Your interpretation of events with Geron runs into the level of the absurd. While it seems you are slowly migrating into being positive about Imetelstat, your statements inherently come from a person not knowledgeable about much of what has, and is, transpiring here.

    Besides not realizing drop out rates and percentages are wrong, as stated by johnson12345, your theory that the breast and lung cancer trials failed to outperform the current standard of care shows your intense lack of knowledge regarding the Geron story. Please, if you're going to write an article about a company, DO YOUR HOMEWORK!!

    There were other factors why these trials were discontinued, they didn't fail and the likelyhood that they will be revisited, in the future, is VERY HIGH.

    Imetelstat is likely to become a pan cancer therapy in the future. If you had any knowledge about the drug, you wouldn't say some of the things you have said recently, and in the past.


  • Report this Comment On January 31, 2014, at 2:16 PM, leviek wrote:

    George....I don't really know you and I'm sure you have good intentions but I read this article again and I just think you write for the sake of writing. I know that's your job and I understand but, Please get to know the companies you write about, get knowledgeable in the situation, and then write about it. Your knowledge regarding Geron, and Imetelstat leaves so much to be desired.

    I understand you are slowly becoming a believer in telomerase inhibition; however, really delve into the history before leading others to false conclusions.

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George Budwell

George Budwell has been writing about healthcare and biotechnology companies at the Motley Fool since 2013. His primary interests are novel small molecule drugs, next generation vaccines, and cell therapies.

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8/27/2015 4:00 PM
GERN $3.08 Up +0.03 +0.98%
Geron Corp CAPS Rating: ***