The All-Everything INSPIRE Interim Review – No Illusions!

I/we are long Onconova Therapeutics (ONTX)

November 17, 2017 – Always do your own due diligence and consult a professional financial advisor before making any investment decision.

No sane person retains a long position in a developmental biotechnology company that is less than two months away from running out of cash. And yet, even after several articles and videos attesting to this fact, many investors seem perilously unaware that this is the predicament we find ourselves in with Onconova. I can attribute this to my limited self-published exposure and the casual investor’s limited due diligence.  It doesn’t help at all that the issue, unsurprisingly, wasn’t addressed directly in the Q&A session that followed the Q3 Conference Call by sell-side analysts covering ONTX.

Once a thriving enterprise with a deep pocketed partner, Onconova is now the ugly duckling of the developmental space with all of its pipeline eggs riding precariously in a shaky interim review basket. With a market-cap of less than $20m and a phase-3 trial not funded anywhere near to completion, this DSMB futility analysis now represents the biggest binary event in recent biotech history. Utilizing five hypothetical press release headlines to capture the five distinct possible outcomes, we’ll examine the effects that these will have on the company and, more importantly, on the share price. But before we do, a brief word about the most recent public offering.

920k New Shares Will Flood The Market Weekly

It has long been stated that equity raises are a necessary evil in the realm of biotechnology investment. That “necessary evil” today is accentuated by excessive executive remuneration and a Wall Street banking system replete with blood sucking greed merchants who work in coordination with each other to line their already bursting pant pockets. A stunning example of this would be Synergy Pharmaceuticals (SGYP) recent equity raise that was a tethered prelude to a loan facility requirement hidden from public view.

That noted, Onconova’s recent stock offering of 920k shares at $1.50 each, though dilutive by discount, hardly constitutes anything that could be characterized as evil or even draconian. Depressing – yes. Evil – no. The paltry proceeds of just over $1m will likely see them through to the interim analysis of INSPIRE and no further. The biggest drawback will be on the upward price movement of the stock as daily over the next several weeks the lion’s share will be sold back into the market for a profit of between 5 and 50%. It’s easy, therefore, to see how wealth begets wealth on Wall Street.

So, why not do a more aggressive warrant laden raise with interest bearing preferred shares that could have seen them through to the conclusive data readout in middle to late 2018? Perhaps, only God and CEO Ramesh Kumar know this for sure but that’s the first question I’m going to try to answer in this article. So, from the least to the most likely scenario we have these three.

  • The equity lenders didn’t see a future beyond this coming interim review that warranted a larger sum of money or a greater corporate involvement (see headlines 1 and 2 below).
  • CEO Ramesh Kumar has thoroughly rebuffed these back alley bankers in order to protect the value of his and our shares.
  • Kumar sees a positive interim review triggering a non-dilutive, income generating event the size and nature of which remains known only to him (see headlines 4 and 5 below).

A Myriad Of Ways To Look At This Offering

It’s clear that Ramesh Kumar seeks to arrive at the interim analysis of INSPIRE with his company fully intact and uncompromised by the vulture capitalists of Wall Street’s underbelly. No one can convince me that he wasn’t given the opportunity to raise ten to twenty million dollars in a creatively structured offering that would have decimated the value of our holdings. By doing so, he could have made it past a futility boundary breach intact. As it is, such an event would likely result in the end of Onconova as we now know it. Kumar, therefore, is either confident of what he has or is rolling the dice like the rest of us are.

For Claity’s Sake – Let’s Play The Hypothetical Headline Game

INSPIRE is not a prototypical phase-3 trial. The structure is far more similar to that of a phase-2 endeavor – open label and unblinded. It’s also adaptive after an interim review the parameters of which have only recently been agreed upon by the FDA and European Medicines Agency. The fact that both regulatory bodies are working closely with the company on all aspects of this trial attests to not only the need for new leukemia therapies but that, additionally, these agencies find therapeutic value in rigosertib. I don’t believe that most casual investors understand any of this. In fact, I think they’re all about to get a heavy dose of due-diligence-neglected when the interim review turns out positive. That stated, the declining share price worries me in that the network of clinical trial physicians is not encumbered by absolute silence. Mitigating these concerns is the multi-country, worldwide stage that this study has been set upon. Therefore, we trudge bravely into the night unaware of the dangers though others might be.

What the casual investor is privy to, however, is that Onconova’s previous big pharma partner, Baxter, bailed after the ON-TIME prelude failed. What they can’t seem to appreciate is that the runway to a return on such a large investment was extended beyond that which BAX could afford to bear. These kinds of pragmatic decisions are made all the time by retail investors but if big pharma pulls the plug it’s assumed the value proposition has altogether vanished. And let’s not forget the graveyard that blood cancers are to promising compounds nor the act of desperation that data mining often is when companies are trying to remain relevant. Is it any surprise then that so many investors have long since pushed onto warmer climes? I think not.

Regardless, and, in fact, because of this, the value proposition here is enormous on both sides of the risk/reward ledger. To illustrate this let’s utilize an analytical tool I just now invented called; The Hypothetical Headline Game. We’ll start with the one press release that no long wants to wakeup to and that every long dreads. We’ll also assign a share price to each event and a strategy. As a reminder, these are products of my tormented imagination only.

Headline #1: “The DSMB Has Stopped Onconova’s Pivotal INSPIRE Trial For Futility”

Of course, that’s not how the actual headline would read because biotech companies always spin to the positive. Instead, you’d likely see something about rigosertib’s substantial treatment effect that failed to reach statistical significance. Unfortunately, the end result would be the same – an intraday sell off that would result in a sub-$5m market-cap accompanied by an inability to raise sufficient capital to fund the pipeline moving forward.

If you don’t think this could happen, think again! There’s lots that we don’t know about the so-called “high-risk” patients from other historical MDS trials that would substantially sharpen our perspective in this one.  I’d be tempted to say that big pharma has access to such data as do large investment funds all of whom have now steered clear of involvement in ONTX but the genetic testing used to identify the ITT population in this study is a relatively new development.  Consequently, fear of the unknown seems to be the factor driving most of the trading paralysis.  Additionally, the incredibly high bar to hurdle for the primary endpoint of overall survival – 37% is dissuading as well.

Stock Price: $0.50 to Zero – Strategy: Stay Away From Sharp Objects

Headline #2: “As Recommended By The DSMB Onconova Will Increase The Size Of The INSPIRE Trial”

This usually indicates that a study is under-powered to successfully achieve its primary endpoint. And because this would be off putting to partnering interest, leaving the company in need of further capital, the overall effect would be a negative on par with an outright crossing of the futility boundary. A smack of reality would likely follow a smattering of hope.

Stock Price: $1 to Zero – Strategy: Stay Away From Loaded Guns

Headline #3: “The INSPIRE Trial Will Advance With Only The Very High Risk Patient Population”

This is the second “shot on goal” that CEO Ramesh Kumar has often referred to in public presentations. What percentage of MDS patients who have failed hypomethylating agents fall into this category I’m not sure but CEO Kumar would undoubtedly be telling us at every opportunity he was given. More importantly, success here would provide Onconova with a foot in the door to commercialization of rigosertib.  If the U.S. market opportunity for second line treatment was between three and five hundred million dollars annually, then that would, at the very least, be cut in half. Whether an ex-U.S. partner would step forward with anything substantial, again, I’m not sure. But the market would likely rally behind Kumar’s narrative.  Interestingly, according to Kumar, the intent to treat population of INSPIRE appears to be weighted toward this group already.  From the Q3 Conference Call we have this remark.

And our prediction was that compared to the previous trial, the new trial which is designed for higher risk patients, the very high risk group would be larger. And I can tell you that that’s exactly what we are finding out that in the new ITT population, the very high risk group continues to be the majority of the patients, a significant majority of the patients.

Unfortunately, a price crushing equity raise chock full of warrants and preferred shares would likely follow.  Interestingly, the company published a supplemental prospectus to this most recent offering detailing an exercise of 3.29m warrants with a weighted average exercise price of $5.10 per share which can be found on page 18.  Though diluting our existing shares by nearly a third, the company would access $16m in badly needed cash.  This might curtail the need for the blood letting I would expect should my $4 target price come true.  In any event, a necessary evil would surely follow in the wake of this news.

Stock Price: $1-$4 – Strategy: Possibly Sell at $4

Headline #4: “Onconova’s Pivotal Phase-3 INSPIRE Trial Will Continue As Planned”

This is the headline every ONTX shareholder would greet with more than a ho-hum sense of relief. It would be validation of both the trial and my investment thesis.  However, I believe that this would presage an even bigger event taking the form of a commercial and developmental partnership that would be announced within days of the news release. Any agreement has to be attractive to both parties and Onconova needs only a small upfront payment of $30m to remain relevant through the INSPIRE data readout in late 2018. That’s an attractive amount to a big pharma entity with a strong oncology sales force (think Celgene). Onconova could be equally demure where sales royalties and milestones were concerned in exchange for full funding of the frontline combination study featuring oral rigosertib in conjunction with Vidaza (azacitidine).

As good as this would be it is nowhere near as good as it gets.  The result, however, would be a soaring share price followed by a standard public offering that we all could live with.

Stock Price: $6-$18 – Strategy: Hold or Sell at the Top

Headline #5: “INSPIRE Is Stopped Early For Success”

This is the extremely unlikely, though not unheard of, catalyst that is almost always followed by news that the trial’s control arm has been moved to treatment with the successful agent, in this case, rigosertib. The stock of said company moves in multiples and not by percentages. What kind of exponential gain are we talking about here? Well, that’s both easy and difficult to explain.

Easy, because the readily accessed patient population represents a potential U.S. market of an honest $300m conservatively and can be addressed by a small sales staff as cancer centers are common domains of cancer treatment. U.S. and European approval would be a foregone conclusion as the company has worked closely with both regulatory bodies and there are no other approved second line treatments.

The terms of that partnership I addressed earlier would be sweetened on both the front and back ends of the agreement with contingencies relative to frontline approval. All of this would spur the market to reappraise the value of Onconova’s pipeline assets and future prospects.

Difficult, because putting a dollar amount to all of this would be hard to do without appearing overly exuberant. Regardless, my conservative guess would be an immediate jump to the mid-30’s followed by a steady climb past $50 per share.  Note that $30 a share would represent a market-cap of only $421.83m a figure I find woefully short of a fair value mark.  Consequently, I believe it would take the market sometime to catch up to the new reality of ONTX.

Stock Price: $35-$50 – Strategy: Buy a Boat

In Conclusion

All signs point to failure.  The market is not enthusiastic about our chances.  That early halt I referenced above is likely a pipe dream born out of a growing sense of desperation surrounding an equity in decline. That noted, every dream realized is in some way founded upon the same shifting foundation.  And those who stand strong must be prepared for whatever comes.  By reading this with comprehension, it is my hope that you’re less likely to slip unexpectedly and that you wobble a bit more gracefully.

Always be well…

Thaumaturgical Disclaimer

As a practicing person of magic and aspiring warm-hearted wizard, I’ve utilized tarot cards as a basis for sub-analysis of biotech equities for the past three years and in my personal life for nearly four decades.

Mental Illness Disclaimer

I’ve been diagnosed as suffering from manic depression. Therefore, my reactions to events can sometimes be more pronounced than the facts warrant. I owe investors complete transparency and am the only ideator in biotech to provide that. Please focus on the ideas presented and don’t hesitate to contact me with any factual errors found in the article text.

General Disclaimer

Any information or opinion expressed herein may not be true, accurate or correct and it does not constitute a suggestion to buy, sell, hold or adopt any investment strategy for this stock or any stock that may be mentioned. Reliance upon information in this article is at the sole discretion of the reader. The sole purpose of my article is to entertain by providing an opinion and information the accuracy of which is as good as the public sources it was derived from. For example, KOL’s often utilize exaggerative terminolgy to describe a product or asset they are promoting on behalf of a biotechnology company they’re associated with. Do not act on anything I have written, a CEO has spoken of, or a sell side analyst has stated. Rather, do your own due diligence and consult a professional investment advisor before making any investment decision. Acting on what any one writer has imparted to you is foolish at best. I have no better access to resources than you do. I sometimes make mistakes. And there are a myriad of things, which can happen in lieu of any forward-looking statement I have made. Any stock featured or mentioned in an article I compose is subject to all manner of influences, which can change its value in dramatic fashion both higher and lower. These events can be of a wide variety – news related; managerial decisions; trial failures; stock manipulations; and so on. I make every effort to declare positions I have in stocks I cover or mention in an article but reserve the right to move in and out of said investments at my own discretion based upon the wisdom of doing so. I implore you to do your own due diligence and invest at your own considerable risk attaining the just reward your efforts have wrought. Additionally, if you are aware of any misstatements of fact contained in this or any article I have written, you are encouraged to email me immediately at the link given in the header above or address them in the comments section

The Slow Motion Crash Of Dynavax

Declaration: I hold no position in Dynavax Technologies (DVAX) and have no intention of initiating a position over the next 72 hours.

  • Today’s near billion dollar market-cap will be cut by 50-75% in one year’s time.
  • Even if approval is granted in November the launch will be abysmal.
  • SEC docs and the CEO’s own words confirm my opinion.
  • A $125m public offering becomes $75m in a day’s time and the offering price is reduced by 19.5% over the August 8th closing price. Why?
  • Biotech CEO’s are today’s magicians – masters of the misdirect.  And Eddie Gray is no exception.

From Michael S Ostrach CFO/CBO Dynavax Technologies August 3, 2017 Regulatory Update Conference Call

Actual results or outcomes may differ materially due to the risks and uncertainties inherent in our business including, for example, the risks we cannot agree with the FDA on the post-marketing study or the label for heplisav-b; whether the FDA will ultimately approve heplisav-b, notwithstanding the advisory committee votes in favor of both safety and immunogenicity; and other risks detailed in the risk factors section of our quarterly reports on form 10Q filed with the SEC.

On a certain night, long ago, while driving the route 26 inbound on Westlake Avenue just north of downtown Seattle, I noticed a motorcyclist whiz by my driver’s side view mirror at some incalculable rate of speed. Such is the nature of frenzy when passion overrides all of our senses. Though he was safely a thousand feet from the bend in the road ahead forged by the lake’s shore, I could already tell that he wasn’t going to make it. Perhaps, he had no intention of navigating the curvature as death will always have the allure of freedom that the chains of suffering in this world lack. More likely, though, he was simply ignorant of the relationship between his speed and geography, captivated by some illusion, subject to distraction, buoyed by hubris, or heaving with emotion. All symptoms of alcoholic impairment and, ironically too, of biotechnology stock ownership in moments of great success.

To the Dynavax shareholder there is only one possible outcome in November – approval of heplisav-b with a follow on Phase-4 study to dismiss the notion of associated cardio or adverse event risks. I’ll identify a more likely and troubling outcome. Shareholders will readily point to the well documented efficacy of the vaccine; the recent adcom in which safety received an overwhelming 12-1 vote of approval (while remaining silent on the importance of the 3 abstentions); and refer you to the conference call following the FDA’s unexpected 3-month delay in which an unnamed agency rep spoke with company execs of a shared desire for expediency in resolving the application, hereafter known as, the head fake.  The most ardent among them will speak of an expanding population of Hepatitis B candidates from the pools of diabetic patients and of an imminent partnership or buyout on approval.  All bungled logic predicated upon wishful thinking.

Affix Oxygen Masks Please

I am now going to detail for you in the simplest possible terms why a short thesis is a far more logical approach in navigating the perilous road ahead.  Deconstructing rosy pictures is not something I like to do but I’ve been fooled by enough by them them over the years to appreciate the value of doing so sooner rather than later.

To reject any advance, saying “no” is only the most direct response.  Other avenues are available to achieve the same outcome.  Where the FDA is concerned, the label now becomes the vehicle upon which rejection, albeit, a temporary one can be implemented.  If it contains a warning of a possible, serious, adverse event risk, resolved only by positive data from a post-marketing study, then commercial uptake of Heplisav-B will be so slow that marketing the drug will be next to impossible.

Biotech CEO’s Are Linguistical Magicians

They have to be!  Their job is to enhance shareholder value.  Complete transparency would undermine that process.  Similar to an accomplished basketball player, they can’t telegraph their next move.  And the head fake becomes an integral part of their game.  Consequently, our job as retail investors is to keep our feet on the ground separating what’s impotant from what’s not in terms of what’s been said.

Can you identify the misdirect in this response by Eddie Gray at the regulatory update conference call regarding discussions with the FDA on the Heplisav-B label?

They seem to have taken two themes from the VRBPAC panel. They talked about how the panel had been very much in favor of the vaccine, represented, sort of, by the twelve-one vote and their other theme, really, was the fact that the panel had been ensuring that the FDA paid attention to the details of the study.

So, we raised the question of the label and I think it’s fair to say that they indicated it would just continue in parallel with our ongoing discussions on the study. We had, of course, been discussing the label with them before the VRBPAC so it’s a continuation of a, sort of, process.

It isn’t hard, is it?  When an adult child calls a parent in need of something, the very first positive statement is prelude to what’s really on their mind.  CEO’s are no different.  The real meat and potatoes of this statement are that the panel wanted the FDA to focus on the details of the application that left a full 25% of them (4 of 16) unable to say “yes” to safety and that these ongoing discussions have been relevant long before the panel convened.

Now, when it comes to head fakes, the one that had most retail investors leaving their shoes came at the 11:39 mark of the conference call when CEO Gray stated this.

Now, obviously, one of the things we want to be doing is working with the FDA to complete the review as efficiently as possible so that it’s not a question and, to be fair, I mean, the FDA, I think, were, you know, very much of a mind that they wanted to move this forward (laughing) Rob, correct me if I’m wrong here, but I think Rob was pressing them at one point on the issue of, sort of, timing and he was stopped by somebody at the agency who said; “No, no, you need to understand, we’re working to get this over and done with as well.”

I have no doubt that the above statement is true and accurately conveyed. But what exactly does it tell you? Who made the remark and is it not something that the agency could and would say regarding any application? Does the statement give you a clear indication of what their ultimate disposition will be? The answers to these questions are painfully obvious to the casual observer. But to those vested in the outcome, the answers can only suggest one thing – approval! Meanwhile, the company goes to the capital markets with shoeless investors holding an $18 share price firmly in place.

Seasoned investors at Cowen, RBC Capital Markets and William Blair, however, didn’t buy the narrative quite so much. They insisted on a near 20% discount on the secondary offering price and there weren’t enough of them requiring a 40% paring of the original $125m ask to $75m. And even then, the offering closed a day late.  I would further argue that the price per share decided upon doesn’t reflect their confidence in Dynavax, Heplisav-B or the FDA so much as their trust in retail investors to provide an early short-term exit point and put options to protect them from downside loss.

CEO’s Aren’t The Only Pump Fakers On The Court Of Biotech Play

Sell-side analysts are adepts at this as well. Take, for instance, William Blair analyst, Katherine Xu. On that euphoric day of adcom relief it was reported by Reuters that Xu tickled new initiates with a SOC market opportunity of $650m for Heplisav-B.

There are so many problems with her assessment that I’m not sure where to begin. So let’s start with Dynavax’s own assesment visa-vie its 2016 Annual Report 10-K filing which indicates a U.S. market of $270m. And while it’s swelling to include diabetics of both the types 1 and 2 variety, Heplisav’s problematic side-effect profile almost certainly precludes them from marketing to this compromised population without a supplemental application reflecting a positive Phase-4 outcome. Consequently, Xu has breached the boundaries of believability by $380m. No small amount.

Put a label on the box that indicates even a possible cardiovascular risk and you subvert the intentions of even the most professional, aggressive and wide spread sales force until such time as the post-marketing study resolves the question. And even if you argue against this conjecture, it’s difficult to argue against a painfully slow uptake of the vaccine when you realize that Dynavax has only an existing supply on hand for the 2018 rollout as manufacturing facilities were mothballed to conserve resources in the past.

From the previously sourced 10-K.

In order to maintain the ability to pursue HEPLISAV-B through the review period we enacted a restructuring plan to suspend manufacturing activities, commercial preparations and other longer term investment related to HEPLISAV-B. If the product is approved, we plan to use existing stockpiled inventory to support initial sales.

This was confirmed by CEO Gray at the regulatory update conference call.

A Cataclysmic Conclusion

Retail investors are banking on approval of Heplisav-B in November.  I haven’t directly argued against that contention because the FDA is loathe to swim against a steep wave of adcom approval.  That noted, they’re in complete control.  A father doesn’t have to say no to his son’s request to drive the car to school 30 miles away.  He just has to leave the tank near empty.

Similarly, if the cost to sell Heplisav-B exceeds projected revenues by too great an amount, Dynavax may choose to run the post-marketing study before attempting a first sale.  And any big pharma partner with the necessary infrastructure in place to sell Heplisav-B will want a clean label before offering an attractive partnership package.

The only remaining option that would provide an exit point higher than that achieved on the day of approval would be a buyout.  And, in the case of Dynavax, that remains a possibility, although, a remote one.

Always be well…

Thaumaturgical Disclaimer: I’ve utilized tarot card readings for over four decades to provide choice guidance in matters effecting my personal life and for three years in the analysis of biotecnology equities. You may not find this credible because it doesn’t meet with your bias towards all things logical, rational and scientific. But if a tarot card reading isn’t in sync with those three elements it is ignored. Too often, however, I’ve ignored a tarot card reading in favor of so-called scientific experts only to be left disappointed. Candle stick chart reading with its doji dragon fly, double hammer and morning star are an esoteric version of scrying utilized by investors in the mainstream to predict price movements. It’s application to biotech equities is often in error and no one complains. But mention a centuries old tradition affirmed by the great mythologist Joseph Campbell and people ready their canons for ad hominem attack.  Fire away!

Mental Illness Disclaimer: I’ve been diagnosed as suffering from manic depression.  Therefore, fire gently!  And never hesitate to contact me first about any factual errors so that I can correct them.

General Disclaimer: Any information or opinion expressed herein may not be true, accurate or correct and it does not constitute a suggestion to buy, sell, hold or adopt any investment strategy for this stock or any stock that may be mentioned. Reliance upon information in this article is at the sole discretion of the reader. The sole purpose of my article is to entertain by providing an opinion and information the accuracy of which is as good as the public sources it was derived from. For example, KOL’s often utilize exaggerative terminolgy to describe a product or asset they are promoting on behalf of a biotechnology company they’re associated with. Do not act on anything I have written, a CEO has spoken of, or a sell side analyst has stated. Rather, do your own due diligence and consult a professional investment advisor before making any investment decision. Acting on what any one writer has imparted to you is foolish at best. I have no better access to resources than you do. I sometimes make mistakes. And there are a myriad of things, which can happen in lieu of any forward-looking statement I have made. Any stock featured or mentioned in an article I compose is subject to all manner of influences, which can change its value in dramatic fashion both higher and lower. These events can be of a wide variety – news related; managerial decisions; trial failures; stock manipulations; and so on. I make every effort to declare positions I have in stocks I cover or mention in an article but reserve the right to move in and out of said investments at my own discretion based upon the wisdom of doing so. I implore you to do your own due diligence and invest at your own considerable risk attaining the just reward your efforts have wrought. Additionally, if you are aware of any misstatements of fact contained in this or any article I have written, you are encouraged to email me immediately at the link given in the header above or address them in the comments section.

Leukemia, Lymphoma and Thyroid Cancers Will Steeply Rise in 2017 and Beyond

My Disclaimer: I wrote this article myself and am being paid by no one to do so.  I am long Sarepta (SRPT).

Summary

  • The end of the world likely won’t come in a merciful, pain-free moment but, rather, as a slow, grinding, disease plagued testament to the folly of human greed.
  • The ongoing disaster at Fukushima Daiichi is unprecedented and will result in many times more deaths than those experienced since the Chernobyl catastrophe of 1986.
  • Consequently, the one subcategory within the healthcare sector that stands to gain the most, and lose the least, in the coming five years is developmental, blood-cancer oriented, biotechnology.
  • My thesis is predicated upon a rapid escalation of illnesses in the coming years due, in part, to the ongoing effects of the 2011 Fukushima nuclear disaster.
  • While there are many possible investment choices at your fingertips, your focus is best narrowed to those companies which now possess or are developing leukemia or lymphoma assets.

Oh, mercy, mercy me.
Ah, things ain’t what they used to be, no, no, no.
Radiation underground and in the sky;
Animals and birds who live near by are dying.

Oh, mercy, mercy me.
Ah, things ain’t what they used to be.
What about this over crowded land?
How much more abuse from man can she stand?

Songwriters: Marvin Gaye, Marvin P. Gaye

© Sony/ATV Music Publishing LLC 1971

A Message To My Followers

I have struggled mightily to convince myself to return to the Seeking Alpha platform.  2015 was a year of great success there with 3-digit gains in Amarin (AMRN) and Synergy (SGYP), as well as near doubles in Trevena (TRVN) and Ocata (OCAT) and 50% or more gains in Seattle Genetics (SGEN); Nektar (NKTR) and Celldex (CLDX).  I was most proud of dispelling the rumors that check point inhibitors such as  Nivolumab would displace Seattle Genetics’ Adcetris in therapeutic indications where CD-30 malignancies were present.  There were, of course, the disappointments in Zafgen (ZFGN) and NovaBay (NBY).  But even in those instances there were things I got right especially in my take on Avenova’s chances of commercial success while ignoring the outstanding warrant issues and my Thaumaturgical analysis of NovaBay in favor of the former CEO’s gobbledygook.

What I miss most, however, is the recognition that my work on TipRanks generated where I broke into the Top 100 analysts out of 9,000 or more, falling back of course, as I withdrew from the Seeking Alpha platform.  But even in 2016 I accurately predicted the approval of Sarepta’s (SRPT) eteplirsen; the equity price upon approval of $60; and that the FDA would comment on the process thereby sinking the equity in approval’s aftermath.  Regrettably, I will not return to ideation on the Seeking Alpha platform because it simply isn’t me.  I’m different.  Unique in ways that make being published there far too painful an experience in an avocation that offers far too much joy.

That noted, I intend to return to biotech blogging in a very, very big way.  I begin that intrepid endeavor here with what I believe is the most important investment thesis you will ever read.  In the future, I will return to Thaumaturgical analyses of biotechnology stocks which is my strength.  As always, you are encouraged to read my disclaimer and to know that it is the most important part of any document or video I publish.  Get ready for the most exciting time in Scrying Biotech history.  Let’s make some money!

Fukushima is an Existential Threat to Humanity

One of many blueprints to successful investing in this sector is to find a change in either a therapeutic landscape or technology that could provide an opening to a greater opportunity. These usually are discovered at the micro level of analysis but sometimes rise to that of the macro. The ongoing ecological disaster at Fukushima Daiichi is as much a profound investment opportunity as it is an existential threat to humanity. It is, therefore, a macabre key that you can use to unlock future profits. I will leave the discussion of how you can best position yourself within the sector to capitalize to a future date.  But, for now, let’s take a closer look at the ongoing calamity itself.

[A conversation recently overheard at my dental office.] Little Girl: “What’s this for?” [referring to the heavy x-ray apron laid over her chest] Dental Assistant: “This protects your heart from radiation.” Little Girl: “What about my head?” [Nervous laughter]

What I’m about to tell you is going to be troubling. So much so that you might want to change the channel of your focus in order to preserve your peace of mind. If you dare stay with me, I fully expect that many readers will become angry. Some will say that I’ve donned my tinfoil hat. While others will proclaim much ado about nothing. Every statement, however, that I’m about to make is properly sourced. And while we might disagree about the severity involved, Fukushima Daiichi is, nonetheless, a severe blow to human life.

Fact! X-ray machines at your dental office give off far less radiation than they once did. And the biennial frequency of exposure may well be worth the cumulative risk. But Fukushima Daiichi is not the one-off event many of us thought it to be back on that dreadful day in 2011. While there are many causes of cancer including, but not limited to, a genetic predisposition; dietary deficiencies; compromised immune systems; viruses; harmful pollutants both passive and purposefully ingested [carcinogens]; and a proclivity towards a sedentary lifestyle, there is also the increasing exposure to radiological elements transmitted through x-rays; roadside speed guns; and outdated nuclear reactor facilities running long beyond their decommission dates. I found several studies demonstrating, for instance, that children age 0-9 living near one of these nuclear power plants were 24% more likely to die from leukemia. And while no one can draw a direct line between the dots, a difficulty that those in the nuclear power industry profit from through liability insulation, it is equally true that no one can deny the association being made, at least, not credibly.

Three Missing Cores At Least One Of Which Cannot Be Located

We were told three partial meltdowns. Don’t worry about it! Now we know it was a 100% core melt in all three reactors.

Quote attributable to, Dr. Michio Kaku, Theoretical Physicist.

Complete transparency on the part of any public or private entity is impossible. We know, for instance, that governments have, for as long as they’ve existed, hidden away facts relevant to any human or manmade disaster. Wanting to avoid a panic is a justifiable motive. Biotech companies do this every day and are given leeway through a number of legal machinations including the cover of patient privacy [see Zafgen (NASDAQ:ZFGN) and Beloranib].

Consequently, the critiques I’m about to make regarding the lack of information provided us by Tokyo Electric Power Company, hereafter, TEPCO, ought not to be interpreted as judgment. I have none. But you need to pay careful attention to the facts I’m about to share with you because they have profound long-term implications for not only Japan but for the Americas as well.

Fact #1: Fukushima Radiation Levels Are Worse Today Than They’ve Ever Been Before

March 11, 2011 will forever be remembered by the citizens of Japan as a day of terror when a 9.0 earthquake located 80 miles offshore and lasting for over 5 consecutive minutes rocked the entire nation. Hours later a massive tsunami had washed away coastal villages and instigated a nuclear power plant disaster unquantifiable in magnitude. Within 24 hours, officials of the federal government and TEPCO had declared the damage to be contained. They further reported that there had only been 3 partial meltdowns at plants 1, 2 and 3, a story they recanted 2 months later.

The situation is now, in many ways, as bad as it has ever been. Of the 4 plants located at Daiichi, plant 4 was able to be shut down. In 2014, spent fuel rods coated with fissionable materials and located in a pool of draining water suspended precariously 50 feet above ground for easy access were removed and placed in a safer location. Plants 1, 2, and 3, however, remain completely unstable. Their fuel rods remain inaccessible. But it is the missing cores in each of these reactors that are causing the most concern.

In Building 2, TEPCO has authorized and deployed the use of several remote controlled robots at a cost in excess of $3m each to find them. Unfortunately, the environment is so hot that the circuitry in the first which looked like a boat fried within an hour and the second which looked like a scorpion was made useless within 2 hours but not before a 6′ gash was discovered in the steel containment structure likely caused by a core burn through. If true, that core is now wedged within the containment floor or resides somewhere on the water table poisoning the Pacific Ocean with a daily dose of cesium and strontium.

In a February 8, 2017 FOX News Insider report, Adam Housley lent credence to just how hot these reactors are by indicating that radiation levels are now being detected at 530 sieverts per hour the highest since 2011. The brave men and women of TEPCO who position and control these robots remotely from inside the buildings operate in shifts of one hour each because it only takes 4 sieverts to kill a handful of people.

Fact #2: Millions Of Gallons Of Radiated Water Have No Place To Go But Back Into The Ocean

When Fukushima Daiichi lost power on that horrifying day, they lost the ability to cool the reactors. So, instead, they began flushing the buildings with sea water. Because sea water contains salt, the pumps used to circulate the water became inoperable. Since that time, approximately 300 to 400 tons of water has been cascaded downhill and into the containment structures of plants 1, 2 and 3 on a daily basis. What doesn’t flow into the Pacific ocean is then pumped out into containment structures made up of steel segments isolated with rubber gaskets. In 2016, there were over a thousand of these barrels containing over 900k tons of radioactive water occupying most of the available land on the hillside property. More durable long-term structures have been built but TEPCO is requesting that they be allowed to bury some of those tanks in the Pacific Ocean in order to complete a process that could take 40-100 years according to experts at a cost of $300bn to taxpayers.

Fact #3: Wind And Ocean Currents Sweep Fukushima Radiation Directly Toward North America

The weeks that followed in the aftermath of the disaster at Fukushima were horrific in their own right. Onshore winds caused for radiation to blow towards densely populated Tokyo. Cooling system failures at the plant were reported on the Sunday following Friday’s debacle and another hydrogen explosion was reported at the plant on Monday. Then, another state of emergency was declared when 3 nuclear reactor units to the northeast of Fukushima were reported leaking and near meltdown at the Onagawa plant.

Sadly, Japan was entering a period where onshore flows were more common thereby endangering more of the inland population. Still, the prevailing wind patterns were, as they always have been, toward the east.  Much of the airborne isotopes fell over the Pacific ocean on their 12-day voyage to Seattle and Los Angeles but the U.S. government reportedly stopped recording airborne radiation levels during that period of time. In fact, it gave no warning to its people that the radiation was about to fall unlike, for instance, the U.K. government which did.

The opening graphic in this article features a map issued by the National Oceanic and Atmospheric Administration in the upper left hand corner depicting the flow of underwater currents from Japan outward toward both North and South America. What is clearly visible is that the land of North America is first in line by sea and by air to be assaulted by Fukushima’s army of radiation. That has already occurred. And while those levels were far below those considered harmful by way of direct exposure that belies a greater truth where the Pacific ocean is concerned as Dr. Helen Caldicott explains.

Radioactive iodine 129 it’s half-life is 17 million years, plus strontium, plus cesium, plus tritium and I could go on and on. If it gets into the sea, the algae concentrated hundreds of times, then the crustaceans concentrated hundreds of times, then the little fish, then the big fish, then us – because we stand at the apex of the food chain. You can’t taste these radioactive elements. You can’t see them. And you can’t smell them. They’re silent.

Long before elevated levels of radiation were discovered in bluefin tuna and sockeye salmon, the U.S. government had already set about to raise the acceptable levels of radiation exposure back in 2013. The problem is that all radiation within the human body accumulates over time. And all forms of radiation are naturally absorbed into the body. The thyroid, for instance, can’t distinguish between regular iodine and radioactive iodine and will take up whichever chemical is presented to it. It is believed that half of all Americans are iodine deficient. Consequently, an uptick in thyroid cancers is one of the first after effects of a nuclear event.  Cesium 137 appears to the muscles in the same manner that potassium does and so on.

Some people will tell you that the 1986 Chernobyl nuclear disaster in the then Soviet Union was far worse than Fukushima because of the 9-day graphite fire that released large doses of radiation into the atmosphere. The weakness of this argument twofold.  First, Chernobyl was located in the vast remoteness of the countryside.  Fukushima is less that 150 miles from one of the most populous cities in the world – Tokyo.   Second, Chernobyl was contained, a word I find grossly exaggerated as a descriptor, on land in a relatively short period of time. It took nearly 600k heroic citizens to dump concrete and lime over the grounds in 10 minute intervals followed by the construction of a concrete and steel dome which has since been replaced to accomplish this. To date, there is no plan to fully contain Fukushima which remains a simultaneous source of oceanic heating and poisoning.

Bizarre incidents of sea-lion starvation have been reported in which NOAA failed to test for either pollutants or radiation as causal factors but, instead, suggested that mothers had to forage further from their offspring to find food due to warmer ocean currents. Fukushima residents on land have been attacked by wild boars which used to be a source of meat on the table but are now carrying doses of radioactive contamination 300-times in excess of acceptable limits. Scientific studies have been conducted to fathom the depth of the problem. And recently, forest fires on the hillsides above Fukushima have released radioactive particles back into the air.

The Elephant In The Room

No one can avoid the obvious – that Fukushima will remain a problem as long as the cores in reactors 1, 2 and 3 remain on the lam. But the real problem that no one wants to talk about is the vulnerability of the site to further earthquake damage which would almost certainly result in a spent fuel rod fire that would make Chernobyl seem like child’s play at a family picknic not to mention 1-million tons of radioactive water in those storage tanks being flushed out to sea. I have little doubt that the U.S. military presence in the China Sea has something to do with the additional concern that Kim Jong Un might target those reactors with conventional ballistic missiles that he already possesses. And the threat of nuclear war looms large in that region as well.

But no matter how one assesses the threat level the truth remains that the worldwide increase of airborne and underwater nuclear contamination is ongoing and rising. Whether related to wars in the Middle East; North Korea’s nuclear tests; failing nuclear power facilities; or the ongoing crisis in Japan – the atmosphere in this world is becoming more toxic every day. And the potential for nuclear power facility meltdowns is increasing as well. The precarious GE design of the Fukushima facility with those suspended fuel rod ponds has been duplicated at 23 other sites worldwide.

Our Investment Thesis Is Simple

We’ll start seeing lung cancer, leukemia, I think, two to five years from now. And then solid cancers will start appearing 15, 16, to 17 years later.

Quote attributable to Dr. Helen Caldicott and previously sourced.

For the people of Japan, there’s no way of getting around this. There are already increasing incidents of birth defects – the pictures of which are too disturbing for me to show you. And while future death rates attributed to cancer from Chernobyl by the UN organization UNSCEAR come in at a modest 3.94k in all of Europe, private scientific organizations not influenced by the nuclear industry peg future incident rates at 16k cases of thyroid cancer and 25k cases of other cancers. Fukushima becomes an added concern with the more lethal dimension of oceanic contamination.

I believe, as do many of my colleagues, that there will be at least a hundred-thousand, and as many as one-million or more cancers in Japan’s future as a result of this meltdown.

Quote attributable to: Arnie Gundersen, FaireWinds Energy Education

I encourage you to view the video linked above and published on YouTube by Mr. Gundersen who is an engineer with over 44 years of experience in the nuclear industry.  Pay special attention to the slides he presents which demonstrate the amount of airborne radiation that the people of Tokyo and Seattle were subject to.  We already know that the incident rate of childhood leukemia has increased by 35% since 1975. Sharp increases in anecdotal incident rates of leukemias in small towns around the world since Fukushima have been reported. And it should be lost on no one that over-all healthcare costs in the U.S. have risen by the most in 34 years.

In Conclusion

Add this all up and we have a compelling case for investment in existing companies with approved therapies in hematological spaces and in developmental enterprises that will give us the new therapies of the future that patients and, possibly even, governments will demand.  In Japan alone, I believe we will seen incident rates of leukemia increase not incrementally but, rather, by multiples.  In a future video, I will show you a company that I’m moving a good deal of my discretionary biotech funds into for the next three to six months that fits this profile.

Always be well…

Additional disclosure: Any information or opinion expressed herein may not be true, accurate or correct and it does not constitute a suggestion to buy, sell, hold or adopt any investment strategy for this stock or any stock that may be mentioned. Reliance upon information in this article is at the sole discretion of the reader. The sole purpose of my article is to entertain by providing an opinion and information the accuracy of which is as good as the public sources it was derived from. Do not act on anything I have written. Rather, do your own due diligence and consult a professional investment advisor before making any investment decision. Acting on what any one writer has imparted to you is foolish at best. I have no better access to resources than you do. I sometimes make mistakes. And there are a myriad of things, which can happen in lieu of any forward-looking statement I have made. Any stock featured or mentioned in an article I compose is subject to all manner of influences, which can change its value in dramatic fashion both higher and lower. These events can be of a wide variety – news related; managerial decisions; trial failures; stock manipulations; and so on. I make every effort to declare positions I have in stocks I cover or mention in an article but reserve the right to move in and out of said investments at my own discretion based upon the wisdom of doing so. I implore you to do your own due diligence and invest at your own considerable risk attaining the just reward your efforts have wrought. Additionally, if you are aware of any misstatements of fact contained in this or any article I have written, you are encouraged to email me immediately at the link given in the header above. Always be well…