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Over 25 years individual investment experience in stocks, bonds, options, and Forex trading. I have developed my own model to find out of favor stocks, stocks with high short interest, and developing technologies for high value investment opportunities. Bachelor of Arts, Criminal Justice:... More
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  • Why Investors Should Seriously Consider Northwest Biotherapeutics A Strong Buy Now

    Just two days after releasing very promising and upbeat news regarding their DCVAX_DIRECT trial, where the company noted premium early indications of the drug's effectiveness, biotech stock antagonist Adam Feurestein launched yet another attacking article against yet another small-cap biotech stock, Northwest Biotherapeutics (NASDAQ:NWBO), casting doubt on a company's public release. Investors have seen plenty of these antics coming from the Street for many years, with one of his most recent attacks being made on Galena Biopharma (NASDAQ:GALE) earlier this year. He has also resorted to attacking MannKind Corporation (NASDAQ:MNKD) on numerous occasions over the past 7 years, and continues to do so to this date. Meanwhile, every single company he has attacked is still standing, and several are on the verge of becoming major players in the Healthcare sector, including Northwest Biotherapeutics.

    The negative viewed article today against Northwest Bio is certainly no surprise to seasoned investors. The Street, and specifically Mr. Feurestein, has a long history of releasing negative articles attempting to dispute the validity of a company's product in trials, or against the company's release of material events data to the public. What is even more striking, and certainly more than just a coincidence, is that every article by Feurestein intended to damage a company's reputation and affect its stock value, is preceded by "tweets" or other message board posts, antagonizing shareholders that a pre-planned event is coming their way, or tipping off short sellers that one is coming to give them an advantage. A "bear raid", so to speak. Another amazing coincidence, or not, is the immediate following, within just an hour to two of the negative article and influencing the stock price pressure to the downside, a plethora of law firms are suddenly issuing press releases that they are "suddenly" representing shareholders in class action lawsuits against the company. All of this sure seems more than just coincidence, if you ask me (and many others). Just maybe, somewhere in our future, the SEC will dig a little deeper and investigate these "timely" articles and lawsuits, and find out just how connected and cynical they really are. If it is all just coincidence, then great!! If not, then something should be done to prevent it in the future. I fully expect that Northwest Bio officials will come out with a statement in the next few days refuting the article.

    At any rate, Northwest Biotherapeutics stock lost 25% of its value intraday based off of the emotional panic created by Adam Feurestein's article. Certainly, based on the substance of Mr. Feurestein's article, the selling was completely overdone, and I believe the stock is a long term buy right now. After reading the article in its entirety, I have come to the conclusion that Northwest Bio officials have done nothing illegal, and the attack on the company is completely unwarranted. In fact, further along in the reading, the doctor admits that "Buzdar said investigators at MD Anderson and the two other hospitals conducting the DCVAX-Direct study have not reviewed or analyzed data at all." So how can the doctor make the statements he made to Mr. Feurestein, if he has not reviewed of analyzed the data. How can he legitimately say what the company reported is inappropriate or an unjustified promotion? And once again, Mr. Feurestein uses the term promotional and unjustified, which is also nothing more than opinion and not based on any facts. In actuality, it is very careless on both parties' part.

    In March 2014, Germany gave Northwest Bio a big nod for its DCVAX-L treatment for brain cancer, even though it has not fully completed the immunotherapy trials yet. In fact, it is the first hospital exemption in Germany for a product never previously on the market, as Northwest Bio's CEO, Linda Powers, stated in the announcement. As well, Germany offered a five year exemption extension to sell DCVAX-L for treatment in all cancer severities, even though it is only being tested in certain individuals for Glioblastoma multiforme (GBM). This kind of government support does not sound like promotional or unjustified reporting to me. It sure sounds more like the German government is very confident in the treatment above and beyond what is currently available to doctors right now, and they are prepared to move forward with it. Certainly, they don't need to wait for the U.S. Food & Drug Administration's slow responses to drug approval to help their own citizens. I fully believe that the German government would not give this type of endorsement if they were not confident that DCVAX-L was the best treatment option our there for patients.

    Northwest Bio's DCVAX-DIRECT trial update, just two days ago, reported that "in the ongoing Phase I/II clinical trial of DCVAX-Direct for all types of inoperable solid tumors, all 9 out of 9 patients who have received 4 of the 6 planned injections are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization of their advanced cancer. In addition, in 3 of these 9 patients, biopsies now show no live tumor cells in the injected tumor." This type of update is exactly what the company should report to its shareholders, and there is absolutely no evidence to suggest that anything reported was false in nature. Any attempt, even by Feurestein or Dr. Buzdar, to rebuke the company's statement is done so with malice and ill intent, and should be discredited.

    MD Anderson, who is conducting the DCVAX Direct trial, and affiliated with Dr. Aman Buzdar, should provide information to the company and to the public to support the doctor's assumptions and statements, or completely retract the statements all together, because it is based on personal opinion, and not whether or not the trial is succeeding or failing. As I noted above, the doctor clearly states he has not reviewed or analyzed any of the data, so how can he make the statements he made? Obviously, Northwest Bio reported information that they received, and that information came from MD Anderson. Therefore, I believe MD Anderson owes the company and its investors and explanation.

    The damage to Northwest Bio's stock price is done, but I believe when everything comes out in the open surrounding this situation, investors will find that the company has not done anything wrong in their reporting, and the company is on the verge of having a product that could be called a "cancer killer." Investors should avoid the rhetoric and distractions being created by the Street and others, including the law firm nonsense, and concentrate on what the trial data are telling us. Those investors who are able to avoid the daily distractions, and focus on the company's promise going forward to the cancer patients, will likely be celebrating with those patients sometime in the near future. Today's price decline in the shares created a tremendous buying opportunity, and I even used the price decline today to add to my long position.

    Disclosure: The author is long NWBO, MNKD. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article.

    Jun 20 8:13 AM | Link | 4 Comments
  • 3 Biotech Stocks Making Big Gains On Big Catalysts

    Biotech stocks can be some of the riskiest and most rewarding investment decision an investor can make. Investors can make huge gains in a very short time, they can take huge losses in an even shorter time, and some can lie dormant forever with no real catalyst events. So far this year, biotech investors have had seen some very big winners, and some very big losers. However, 3 biotech companies in particular are making huge news in the markets and throughout the biotech community. Northwest Biotherapeutics (NASDAQ:NWBO), DARA BioSciences (NASDAQ:DARA), and MannKind (NASDAQ:MNKD) have leapt to the forefront with huge catalysts developing. All 3 companies also boast some of the highest short interest percentages among any other listed company.

    Northwest Biotherapeutics, Inc.

    Northwest's stock has been all over the map in the past few months, recently falling down to the $5.50 trading area, but today the company released some very impressive data from their DCVAX-DIRECT trial that sent shares roaring to the upside. "In the ongoing Phase I/II clinical trial of DCVAX-Direct for all types of inoperable solid tumors, all 9 out of 9 patients who have received 4 of the 6 planned injections are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization (i.e., stopping the progression) of their advanced cancer. In addition, in 3 of these 9 patients, biopsies now showed no live tumor cells in the injected tumor." MD Anderson, who is conducting the trial, is one of the premier centers for cancer drug development in the U.S.

    The news released today is a major catalyst for the stock, and it is expected that the company will be releasing further updates soon. Some investors even expect that updates could begin coming on a weekly basis as the trials progress. In any event, the news today is very big for Northwest and investors should take notice of it. Although it is still early, the last news released of this magnitude from a company was when Intercept Pharmaceuticals (NASDAQ:ICPT) announced the early stoppage of their FLINT trial due to overwhelmingly significant improvement in January 2014. The same could happen for Northwest, and investors probably know the kind of gains ICPT made on their news. Some investors believe the news is even bigger and better than the news ICPT released when its stock soared over $440.00 a share. Northwest could make a similar run with huge gains, and investors should keep a close eye on developments as they are made public.

    With only 35.3 million shares in the float, over 21% of the float sold short, and a very undervalued $500 million market cap, NWBO could make some very strong gains should the DCVAX-DIRECT trial continue to prove to be a true "cancer killer." In my opinion, the current share price does not reflect the news that was issued today, even though the stock did gain $1.16 to close at $8.82 a share. I believe the shares have a very significant long term price appreciation ahead of it, and current prices are a ground floor opportunity for investors to consider climbing aboard. The idea of NWBO trading above $200.00 a share may sound absurd and like a complete fantasy, but the likelihood is very realistic if the trial continues to prove as successful as it has already shown.

    DARA Biosciences

    DARA Biosciences is small biotech company that made huge headlines in the news, when the stock gained 14.3% to close the session at $1.28 a share. The company announced that their intravenous, non-opioid, non-narcotic compound to treat Multiple Myeloma, KRN5500, was granted Orphan Drug status by the FDA. In 2011, the FDA designated KRN5500 as a Fast Track program which expedites the development pathway and consideration for priority review. Orphan Drug Designation provides DARA with seven years market exclusivity from the time of approval, tax credits, and the waiver of PDUFA filing fees, as well as access to federal grants.

    With only 6.4 million shares in the float, almost 14% of the float sold short, and a market cap of only $10.75 million, DARA Biosciences is definitely a long term story that investors may want to take notice of right now. Having a 2nd orphan drug status placed on KRN5500 only makes a stronger case for the possible success of this drug to reach market. The company boasts cash per share of $1.16, and even with the 14% gain after the KRN5500 news hit the markets, the shares should still be considered undervalued by a large margin. Investors who have a long term horizon could easily be looking at significant gains in the future, should DARA continue to release positive updates and developments. In my opinion, the news released today is not completely priced into the stock, and upward momentum should be expected to continue heading forward. With its current cash on hand, and taking into account the positive aspects surrounding KRN5500, I put DARA Biosciences stock value about $4.00 a share.

    MannKind Corporation

    MannKind has been seeing very high volume over the past several weeks, as the company awaits an FDA decision for its ultra fast acting inhaled insulin, Afrezza, on July 15, 2014. After surging 97% after an overwhelming 27-1 Advisory Panel vote recommending approval on April 1, 2014, the stock plunged backwards after the company announced a PDUFA extension, but has now recovered and is sitting very near all-time highs at $10.65. The company recently updated investors on several occasions regarding talks with multiple potential partners to market Afrezza should the FDA approve the drug.

    MannKind has a much larger float than the two companies profiled above, but MannKind has a game changing product in the diabetes market, if they get the nod. With 242.2 million shares in the float, over 30% of the float sold short, and a market cap of $4.0 Billion, the company still demands huge attention from investors going forward. Afrezza would become the a first in kind treatment for both Type 1 and Type 2 diabetes, a global market worth roughly $35 Billion today and targeted to be close to $60 Billion in 2018. The company has also recently reported their interests and pre-clinical phase of entering the pain management market once they got approval on Afrezza. The pain management market is another $60 Billion global market.

    There have been several opinions written regarding MannKind's lack of a partnership announcement, but it sure appears that the company is closing in on a deal that could be announced at any time. An FDA approval and a major partnership announcement will almost surely send shares soaring to much higher levels. Should MannKind receive approval from the FDA for Afrezza, investors should sit tight and not sell the news so quickly, as a partnership announcement would likely not be far behind. Also, the next phase of MannKind taking their Technosphere platform into the pain management market would almost surely send the shares even higher. The Technosphere platform has many possibilities and could cross into a number of drug areas, so investors with a long-term horizon definitely have something to look forward to in the years to come. In my opinion, investors have not factored in the Technosphere platform future possibilities as of now, but validation of the platform with an FDA approval of Afrezza, will surely add significant value to MannKind's market cap. Nevertheless, a rejection by the FDA would be devastating and the shares would likely take a very nasty fall that an investor might never be able to recover.

    Summary

    Biotech stocks can make or break an investor. They can soar to unimaginable levels as good news hits the markets, and they can sink like the Titanic when bad news hits the markets. The 3 biotech stocks noted in this article are clearly some of the better risk vs. reward options for investors to consider. Each one of these stocks could keep making very big gains if developments continue to be positive. However, one small hiccup could be costly, so investors should always be cautious when investing in risky biotech stocks. Yet, the rewards from hitting the homerun could make an investor's portfolio very healthy.

    Disclosure: The author is long MNKD, NWBO. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article.

    Jun 17 11:14 AM | Link | 2 Comments
  • MannKind Shares Keep Rising As Short Seller Myths Continue To Be Discredited

    MannKind Shares Keep Rising As Short Seller Myths Continue To Be Discredited

    MannKind (NASDAQ:MNKD) shares have risen from around $7.00 a share to close at $10.04 as of yesterday's trading session, since my last article on MannKind. As of the last short interest report, almost 30% of the shares are short, which equates to more than 68 million shares. The large short interest is a result of several years of misinformation relayed to investors in the past, and largely accountable to the Street's Adam Feurestein. The timeline of events that have occurred over the years explains the recent desperation by the large short interest to control the price of the stock, hoping for denial by the FDA to approve Afrezza. Obviously, the short sellers are in trouble here.

    Afrezza has been on the target list of shorts for several years. However, every tactic used by the shorts has been thwarted time and time again. When Afrezza first came on the scene, short sellers used the failure of Pfizer's Exubera as the main reason why Afrezza would fail. It wasn't long after the trial data was released; that the short followers found out the Afrezza was for real, and completely different than Pfizer's failed product.

    Heading into the 2nd CRL, shorts again were sure of the demise of Afrezza and the short sellers increased their position in the stock. The 2nd CRL called for additional trials, which were completed by MannKind, and the data release once again thwarted any signs of demise for Afrezza, and actually improved the chances of approval. Yet still, after the trial data was released, the Street's Adam Feurestein continued to claim that Afrezza would be rejected by the FDA. In fact, he called for 60% chance of rejection, by what he noted as, " The BEST Afrezza FDA Panel Review Ever", where he continued to lead investors into shorting the stock absolutely sure of rejection by the Adcom Panel. Leading up to the Adcom the short sellers were all-in making claims of FDA concerns regarding Afrezza being tied to lung tissue function, which none of the trials ever showed in the data. The short sellers even made claims that data was missing, and the FDA would reject Afrezza once again.

    After an intense and very astounding presentation by the company and actual trial patients, the "best ever Adcom panel" voted overwhelming 27-1 to approve Afrezza for both Type I and Type II diabetes. Of course, the stock gained significantly in value in the afterhours session on the news, and it took no time for the short sellers to change stories once again, and claim that the FDA would not approve Afrezza based on lung cancer concerns, or a label so restricted, that it would not be accepted in the market. Even though the ALL of the trials conducted, even the additional FDA trials requested after the 2nd CRL, showed absolutely no pulmonary neoplasm's, the short sellers piled into the stock again knocking it off a new 52wk high of $8.70. How the FDA can restrict a label for cancer that none of the trials ever showed is beyond me, and I would be very shocked if the FDA did this at all. Even the Adcom panel would have voted differently had they seen this risk. This is yet another myth of the shorts that has been thwarted again.

    Now that the chances of approval have grown significantly, short sellers have now switched their tactics once again; even after all of their other claims have been discredited over the years, now they are targeting MNKD's valuation and balance sheet, and lack of a partnership, as the reason for their sticking around. Some are even comparing it ultimate value after an approval to other biotech stocks that are not even in the same market. Adam Feuerstein has even now offered a full published apology on his botched Adcom panel article since that time too, but too late to save all those who followed his advice of Afrezza's demise and shorted the stock. Even Piper Jaffray rode the short bandwagon, and after the Adcom vote, renigged their sell rating.

    Within a few weeks, investors will find out the fate of Afrezza, and I believe the chances of full approval without restrictions is 95%+ based on the Adcom panel review and vote. The FDA is likely to ask for a post approval study for lung cancer risk as part of the approval, but I would have never expected less with anything inhaled, but it certainly does not mean something is wrong with Afrezza, or that it causes cancer. The fact is, all the trials show otherwise. This post approval study will likely used as a monitoring study for Afrezza users. Nothing alarming like the short sellers would like you to believe. Several articles have been written over the past few months to show how undervalued MNKD shares are right now, based on sales potential and market penetration. MNKD is still a ground floor opportunity for all investors willing to hold long term. Short term volatility will occur, especially leading up to an FDA decision, and should be expected. Ultimately, those who stand their ground and not worry about the day to day fluctuations will be successful.

    Personally, I can't wait to see what the short sellers come up with next. In the meantime, MNKD shares will continue to climb, as I believe some short sellers are pulling out of their losing position and moving on. I also believe the shorts are very close to starting a short squeeze of their own making against themselves. Many brokerage firms have already raised their margin requirement for MNKD to 100%, and triggering those stops, will create automatic buy-in margin calls against the shorted stock. This will create even sharper price increases for MNKD shares. Also, I believe institutions are beginning to stake their claim in MNKD prior to approval. Once approved, the shares are likely to spike to levels that will make CNBC headlines for several days. With a short interest this high, patient investors will be FULLY rewarded on an FDA approval announcement, and again with a partnership announcement. There is nothing more fun in the stock market to watch short sellers scramble for the exit and try to leave their fellow short sellers that last one out the door.

    In my opinion, MNKD shares will trade significantly higher heading into the FDA decision, and likely double from there on approval. A partnership announcement along the way will be added fuel to the fire. With the amount of trading volume this week alone, shares have to be getting more and more scare, since Al Mann and his groups own the largest portion of the outstanding shares. Opportunities like MNKD don't come around often in the markets, and those who sell now will definitely wish they had stood strong amongst all the short sellers and their deceitful tactics. With such a strong Adcom vote, I doubt the FDA will need the full 90 days to approve Afrezza.

    Disclosure: I am long MNKD.

    Tags: MNKD
    Jun 05 11:37 PM | Link | 25 Comments
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