CTIX - 2013 Stock of the Year

The race to a $1 trillion market capitalization was all the rage amongst analysts as they clocked the growth rates of Google and Apple in recent months. That talk has cooled for the time being with the recent fall in value of both companies, but it does get one thinking about the possibilities and where better values might be for returns. The reality is that only the most elite companies could ever reach that valuation and making it there would only produce about a 70 percent return on Apple from its recent peaks. For Google, the returns would be in excess of 300 percent, but the stock price would need to climb from current levels of $670 a share to over $3,000 per share with its current structure.

Digging deeper shows that even a $100 billion market cap is quite rare in the grand picture with only about one-third of one percent of public companies trading in the U.S. markets achieving that mark. Reaching $10 billion is a daunting task, but far more realistic, with in excess of 500 companies cracking into that club and many more knocking at the door.

The best chance for success – and unparalleled ROI – is focusing on biotechnology companies. A look at a list of the biggest companies by market capitalization shows a myriad of biotech stocks. In fact, 6 of the top 50 companies (12 percent) in the U.S. by market cap are biotech, including 3 in the top 20 (15 percent). Of course, this excludes leading drug makers like Roche, Novartis and Merck because those $150-billion-market-cap companies are headquartered overseas, even though they trade on the U.S. markets.

Overall, there are about 20 U.S.-listed drug making companies that have broken above the $10 billion barrier for market capitalization with several others, such as Forest Laboratories (NYSE: FRX) that were recently sitting on the cusp.

Putting aside companies like Forest Labs, trying again to break back above $9 billion, there are other some smaller biotech’s, that have a strong chance to mushroom in value with their pipeline of products. In order to make prescient decisions in choosing a company, it is imperative to find the right field that can shoulder exponential growth. Pharmasset (formerly NASDAQ:VRUS) demonstrated the prowess of targeting an oral drug for Hepatitis C to compete with today’s standard of care, the injectable interferon, that can often times be poorly tolerated by patients. In mid-2007, shares of VRUS could be bought for $4 per share. As Pharmasset’s experimental drug, PSI-7977, moved through early stage and mid-stage clinical trials, shares rocketed to about $160 per share before a 2-for-1 forward split brought prices back down to $80 each. After another modest climb, Gilead acquired Pharmasset in November 2011 for $11 billion, or $137 per share…and the drug wasn’t even done with Phase II clinical trials. The ROI for shareholders in around $4 was a whopping 6,750 percent in four years. Incidentally, over the same period, Apple has produced a ROI of about 500 percent when it peaked about a month ago.

It’s this type of due diligence and foresight to hone-in on the most promising growth areas that has me looking at specific cancer areas of oncology for companies poised to experience Pharmasset-type of price movement. Why? Because cancer is still a leading global killer in dire need for new therapies – not simply reformulations of existing drugs – to destroy tumors. In order to meet the criteria, a company must be under $5 per share, have a unique product candidate that targets a large patient population to meet an area of unmet medical need and also have a strong pipeline that adds value through addressing additional indications. These characteristics will not only build share value on their own, but certainly grasp the attention of big biotechs for their starving pipelines.

There are several prospects that command attention, but limiting the list to companies already in clinical trials, the best candidate for a steady rise in share price potentially leading into an explosion is Beverly, Massachusetts-based Cellceutix Corporation (OTCBB: CTIX).

Cellceutix is young company that slips past many big board players, but offers one of the largest upsides of any traditional drugmaker because of the uniqueness of its flagship drug. The first doses in clinical trials of Kevetrin™, the company’s flagship anti-cancer compound, are now being administered at the vaunted Harvard University Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center. Kevetrin™ is no ordinary cancer drug. Its Mechanism of Action (MOA) acts upon the crucial tumor suppressing protein p53, referred to as “The Guardian and of the Human Genome” because its job as master regulator of the cell cycle. In nearly every cancer case, p53 is disrupted in its duty to induce apoptosis (programmed cell death) and shunt cancer cells from dividing uncontrollably.

The clinical trials at Dana-Farber and Beth Israel are evaluating Kevetrin™ against a wide array of solid tumors. Where many companies have to try and delineate a cancer line that their drug may prove a therapeutic benefit, Cellceutix is afforded the luxury of a basket of tumor strains because muted p53 activity is a culprit in nearly every type of cancer. That type of potential is unmatched by any peer.

Kevetrin™ has been extensively researched in the lab against many different cancer lines, including breast, lung, colon, leukemia, prostate and more, for which the company can boast the drug outstripped controls in slowing tumor growth and shrinking tumor sizes in each. The reason for the strong results stems from the MOA which shows Kevetrin™ helps p53 re-assume its normal function as a tumor destroyer. This opens the door for Kevetrin™ to become a front-line defense for any cancer diagnosis if the data is replicated in humans. As it stands, the stock seems undervalued at 95 cents, but when preliminary data starts to stream in from Dana-Farber and Beth Israel, the stock should see substantial, rapid appreciation in value.

Kevetrin™ is also readying to undergo additional studies being funded by Beth Israel in combination with Pfizer multikinase inhibitor drugs as potential new therapies for renal cancer and melanoma. Moreover, Cellceutix announced that a major university in Europe has approached them to sponsor and host additional research on Kevetrin targeting leukemia in combination with drugs from one of the world’s biggest pharmaceutical companies. That protocol for clinical trials is being written currently, according to Cellceutix. Trials could commence as soon as the first quarter of 2013.

Two major pharmas? Some of the world’s foremost cancer hospitals? Major players approaching Cellceutix and offering to pay to run clinical trials? These are very rare happenings and outwardly validate the potential for this small company’s new drug.

Adding to its pipeline in development, Cellceutix is having its anti-psoriasis drug, Prurisol, formulated by Dr. Reddy’s Laboratories (NYSE: RDY) for a Phase II clinical trial late Q1/early Q2 next year. Psoriasis trials are generally pretty brief (either the drug works or it doesn’t), so data from that clinical research could arrive by the start of the second half of 2012. Lab studies produced stellar results showing Prurisol eliminated virtually any trace of psoriatic tissue in animal models comparing Prurisol to methotrexate, a standard of care today. Prurisol making it to market is another multi-billion dollar proposition for Cellceutix.

Given the shallow pipelines of major pharmaceutical companies, Cellceutix is a premier early-stage acquisitions. They have a connection with Pfizer already and have relationships with other major pharma as evidenced through Non-Disclosure Agreements. Merger and acquisition activity in the biotechnology space is soaring in 2012 and analysts expect the pace to quicken as patent cliffs are sucking revenues from the world’s leading drug makers. Shareholders may not even want Cellceutix to be an acquisition target as the valuation is too low at this moment. As the company continues to develop its pipelines, the valuation should rise on its own and accommodate merger activity at much higher future prices.

When it comes to sheer, raw upside potential, Cellceutix is a standout and possesses the type of headroom for growth that will soon command investor and analyst attention. Others can chase Google and Apple, but the bigger plays are in biotech; you just have to know which one.

TAGS: Apple, Beth Israel, Google, ROI