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The Most Exciting Idea in Biotech

In mid-August I discussed 9 Compelling Reasons to Own Opexa (NASDAQ:OPXA) Therapeutics Right Now. The publication of that article coincided with the precise bottom for Opexa shares, which have since rallied as much as 85%. Today I discuss a company that has even more appreciable upside: Novogen (NASDAQ:NVGN). In fact, Novogen is the most exciting opportunity I have seen in the biotech sector in years. I believe purchasing shares at these levels may be akin to buying Regeneron (NASDAQ:REGN) at $5 in 2005 (currently trading at $296) or Pharmacyclics (NASDAQ:PCYC) at $4 in 2011 (currently at $127). Below I discuss an immediate under-the-radar catalyst that should send shares soaring, followed by a longer-term investment thesis.

Imminent Deal in the Works

In his July letter to shareholders, CEO Graham Kelly advised investors to expect "considerable potential news flow coming up over the next 12 months." A hidden jewel shedding further light on this news flow is contained on page 27 of the executive summary of Novogen's annual report, released in the last week of September. The company hints at two significant developments in the works. The first, regarding the "acquisition of a novel drug technology," was just recently announced. More significantly, the second announcement involves an intention to announce a "collaborative structure that will allow the Company to work towards its goal of individualized chemotherapy." Rarely do investors get the chance to buy shares of a company ahead of such a well-telegraphed announcement. This gem in the report appears to have been entirely overlooked by the market. I see no mention of it in any article, on any blog, on Twitter, or any message board whatsoever. This news could hit the tape at any moment, and will be announced by the end of the year at the very latest. My expectation is that a major pharmaceutical company with an extensive background in ovarian cancer treatment, such as Merck (NYSE:MRK) or Bristol Myers (NYSE:BMY), may partner with Novogen. Such a partnership would be pocket change for any major pharma, and would represent a dirt-cheap option on the groundbreaking science Novogen has exhibited thus far. Details follow of precisely how extraordinary Novogen's drug platform has been to date.

Revolutionary Approach to Killing Cancer

"We firmly believe we are on the road to conquering cancer."

"We believe that we are on the verge of a quantum leap forward in chemotherapy, with long-term remission across most forms of cancer a realistic possibility."

These are the bold, impassioned words from the CEO of Novogen, an under-the-radar company that may offer the best chance of eradicating multiple forms of cancer of any early-stage company in existence today. Of the 13 anticancer drugs the Food and Drug Administration approved in 2012, only one may extend life by more than a median of six months. Two extended life for only four to six weeks. Herceptin, Avastin, and Zytiga have enhanced the market capitalizations of their respective manufacturers by billions of dollars even though their drugs exhibit only marginal survival benefits.

In contrast, Novogen's approach to fighting cancer represents a new paradigm. Though Novogen's initial focus is on ovarian cancer and glioblastoma multiforme (GBM), its ultimate mission is to "eradicate all cancer cells from the body, in all patients and irrespective of the type of cancer, and to do that with minimal toxicity" and to be the "principal supplier of drugs that provide long-term remission through the successful control of the cancer stem cell." Cancer stem cells are the key to cancer's ability to grow, spread, and survive attempts by the body and by oncologists to destroy it. They are highly resistant to traditional means of combating cancers including chemotherapy and radiotherapy. None of the current anti-cancer drugs shows any meaningful impact on cancer stem cells. Novogen is at the vanguard of this exciting approach in the fight against cancer. Significantly, Novogen is seeing "little toxicity" compared with the ravages of traditional chemotherapy. Please click here and here for further details on the intricacies of the revolutionary science behind the Novogen platform.

The Ultimate Endorsement

An article in a local Australian paper earlier this year whose headline reads: "A Willing Guinea Pig for Radical New Cancer Drug" details just how much faith CEO Graham Kelly has in his company's drug. Kelly was suffering from advanced and aggressive prostate cancer when he injected the earlier versions of the company's experimental drug on himself. Kelly is in complete remission and is feeling great; all indications are that the experiment was a resounding success. Remarkably, the latest incarnation of the drug is considered superior to the one Kelly used to treat his cancer. Though Kelly does not advocate others replicate his radical experiment, it does provide us with a unique human case study prior to actual clinical development of the drug.

Multiple Other Catalysts

In addition to the immediate "collaboration catalyst" discussed above, investors have multiple other events that should lead to significant price appreciation. Novogen's April newsletter discusses its expectation for Breakthrough Designation from the FDA for its CS-6 in 2014. Published on its website and largely unnoticed by the investment community, Novogen's August corporate update is among the most bullish statements I have ever encountered from a biotech company. CEO Kelly states in that letter that the company's flagship drug CS-6 has "considerably greater potency than anything we have encountered before." Kelly also affirms that the CS-6 program is on track to have all necessary data in by November 2013 to be in clinical development in 1Q14. If these data confirm the preliminary findings in February that launched Novogen's shares from $2 to over $10, I would expect a similar parabolic move in the stock. Judging from the tenor of management comments in the annual report and recent shareholder updates, I believe this is a high probability event. I would expect to see "holy grail" type headlines in the media reminiscent of Geron (NASDAQ:GERN) or Entremed (NASDAQ:ENMD) back in the late 90s. Only this time, Novogen holds much more promise than those stories of hope back in the day.

Valuation

The market capitalization of Novogen is a mere $22 million. Yet, the promise of Novogen's drug platform is exponentially higher than any other early stage biotech, many of which are currently valued 10x higher than Novogen's capitalization. Evidenced by the preliminary ovarian cancer data that exceeded even the highest expectations, Novogen clearly outshined Cyclacel's (NASDAQ:CYCC) preclinical ovarian cancer data, as one example. The Street is willing to assign multi-billion dollar market caps to oncology bio-pharmas that focus on one drug for one cancer that may extend life by only a few months. Even assigning an infinitesimal probability to the ultimate clinical success of Novogen's drugs yields a market valuation far greater than where shares currently trade. Rarely if ever have I seen the Street so grossly misprice a stock relative to the prospects of the underlying company.

Risks

Is this story too good to be true? Shouldn't a company that could potentially eradicate cancer be valued at $22 billion and not $22 million? As I have made quite clear, I believe the Street is severely undervaluing Novogen shares due to lack of coverage and a misunderstanding of the recently reincarnated company. As with all early stage biotechs, however, Novogen is a highly speculative investment, and human trials often do not mirror what is found in the preclinical laboratory. Thus, even as I believe Novogen will be a triple digit stock if human trials confirm the current data in the coming years, this is a highly speculative investment. I also believe investor confusion/misunderstanding has contributed to the depressed share price.

Insider Ownership and Financing

Top executives Graham Kelly and Andrew Heaton own over 12% of the company shares on the Australian exchange. Hudson Bay Capital financed the Triazal Pharmaceuticals transaction which enabled Novogen to acquire the transformative science currently being tested. In a sign of confidence, Hudson Bay agreed to be repaid in stock only upon the completion of three key milestones: successful completion of a Phase 1a study, grant of IND or Breakthrough status, and successful completion of a Phase 2 study. In July, Novogen secured additional financing with Hudson Bay Capital under terms "considerably more favorable" than those initially approved by shareholders in May. This financing is sufficient to take CS-6 well into the clinic.

Summary

We firmly believe that we are on the verge of changing forever how we treat cancer. Not just any one form of cancer and not just with the goal of prolonging life be weeks or months.

Novogen shares present a compelling speculative opportunity at these levels, whether one's time horizon is a few months or multiple years. The principal intention of this article is to shine a light on a hidden gem provided in the annual report; namely, that a potentially groundbreaking collaboration is to be announced in the near future. Additionally, November 2013 ovarian cancer data, 2014 Q1 clinical Ph1 initiation, and 2014 Breakthrough Designation status, represent additional catalysts for further share appreciation. Preliminary studies demonstrate remarkable success at attacking formidable cancer stem cells. If these exceptionally promising results are replicated in clinical trials, Novogen may ultimately become the most valuable biotechnology company in the marketplace. Unlike virtually every other major oncology-focused company today, Novogen's mission is not merely to extend life by a few months, but is resolutely focused on eradicating all forms of cancer in all patients -- complete remission -- just as the CEO himself has experienced with his own drug. A noble, ambitious goal indeed -- and one Novogen firmly believes it is on the road to fulfilling.

Source: Novogen Is Poised To Soar As A Major Partnership Announcement Is Imminent