CYCC And ONTX: Intertwined By Destiny

I/we are long CYCC and ONTX.

The spirit of wickedness in high places is now so powerful and so many headed in its incarnations there seems nothing more to do personally than to refuse to worship any of the hydras heads. The world seems little better than a new Tower of Babel – all noise and confusion.

1969 J. R. R. Tolkien

It’s been very difficult for me over the past several years to have steered close friends toward investment in German biotech, Pieris Pharmaceuticals (PIRS) while refraining to mention my clandestine love for the two step-children of developmental oncology – Onconova Therapeutics (ONTX) and Cyclacel Pharmaceuticals (CYCC).  You see, I believed then, as I do now, that Pieris is the safer bet to appreciate over time.  But safety comes at a price.  And since I’ve never been a big fan of turtle racing, preferring faster paced adventures, I’m betting on the two unattractive step-sisters of failed Phase-3 endeavors instead.  That now stated, Onconova and Cyclacel have much more in common than the high-minded reproval of sector elites relative to their Phase-3 flops.

Both Company’s Lead Drug Candidates Still Have Life

You wouldn’t know it by observing Onconova’s paltry market-cap of $26m but rigosertib is in yet another and far more promising Phase-3 study entitled; INSPIRE.  More promising because it is structured upon culled data from 116 of the 299 patients in the ONTIME study that fell nicely into a category labeled “high risk” and responded brilliantly to rigosertib therapy administered intravenously.  Had this population of patients been the focus of a large Phase-2 trial with an over all survival benefit of 7.9 mos. vs. 4.3 mos. in control (p = 0.0008) the market-cap of ONTX heading into Phase-3 would be in excess of $300m.  Alas, it wasn’t.  And Onconova is teetering on the brink of insolvency or, at least, crippling financial impairment.

Meanwhile, Cyclacel has moved on from the unraveled SEAMLESS pivotal study mentioning sapacitabine only as an aside in their corporate presentations.  Their second generation CDK2/9 Inhibitor now stands atop the pipeline depth chart.

Make no mistake, though, CEO Spiro Rombotis has his eyes pinned on the results of Onconova’s INSPIRE study as it will become a referendum on the future of sapacitabine.  You see, SEAMLESS had one very significant feature – a substantial increase in the amount of Complete Remissions (CR) in targeted elderly AML patients age seventy and above.  Rombotis, to this very day, alludes to submission for regulatory approval in the EU for sapacitabine on the basis of this one secondary endpoint in conjunction with Dacogen approval given on a failed, Phase-3 registration effort.  And while on its face that seems laughable, his case could be bolstered by INSPIRE success because Onconova CEO Ramesh Kumar will then take to plugging the frontline trial of oral rigosertib in combination with azacitidine which will highlight a primary endpoint of…wait for it…Complete Remissions.  How long will it take Spiro Rombotis to begin referencing rigsertib’s pathway as a model for sapacitabine regulatory approval?  And whether the comparison is valid or not, the market of easily influenced retail investors will lap it up driving CYCC’s stock price higher and higher.

Concluding Remarks

While rigosertib is pulsating with life in a promising pivotal fight, sapacitabine rests on the sideline ready to awaken if rigosertib rises from the dead.  Cyclacel, with its bloated $40m market-cap, sea of warrants and preferred shares, at a glance, seems less attractive than Onconova.  But its financial position, by comparison, is enviable.  Both companies have late generation CDK Inhibitors to develop if the door closes on those earlier assets.  But the play here is to bet that there’s more than a crack in the opening to relevance for both rigosertib and sapacitabine forming a widening wedge of investment light.

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.

A Message To Spiro Rombotis – CEO Cyclacel Pharmaceuticals

I am long 2,036 shares of CYCC and adding.

Dear Mr. Rombotis,

I feel compelled to share with you a Thaumaturgical analysis I conducted on CYCC today, Friday, April 21st 2017.  The messaging in this analysis is more important for you than it is for shareholders.  And by “shareholders” I don’t mean any investment bank you work with, hedge fund(s) or institutional equity holders (which are coming in).  I mean retail investors such as myself.

My guides are telling me that this is a new beginning for the company.  The importance of this new beginning can’t be understated.  It has sparked a genuine interest in the company.  And while Adam Feuerstein, with motives known only to himself, has derided and derailed this fresh start it, nonetheless, is a very real phenomenon worth building upon.

At the present time, we see that you are troubled.  Your tendency, as it has been in the past, is to pull away into yourself as a means of managing your emotions.  You must avoid this.  But the only way to do this successfully is to think of your retail shareholders first, last and always.  And this is clearly not what you have done in the past.

At the present time, you are receiving your first genuine partnership interest revolving around CYC065.  Big pharma knows that you are in a distressed financial situation not as it pertains to your runway of cash under current operating conditions but as it concerns any ambitions you have for placing CYC065 into a large enough Phase-2 trial to engage the FDA in Accelerated Approval discussions on a positive outcome.  Consequently, the offers are, and will be, far below what you would hope to entertain.  Regardless, you must not become depressed by this to the point of withdraw or becoming jaded.  To keep the proper emotional disposition, keep your arguments focused on what’s best for your shareholders.  You should note that this is what you’ll be hearing from your over fed counterparts.  And while it comes across as disingenuous it is effective.

In Q3 you will be fielding offers from two parties.  You must be careful not to play one off against the other but, rather, to treat each as an opportunity to gain clarity on mutual benefit.  A large upfront cash payment will likely not be proffered given the fact that a smaller amount will be viewed by the supplicant as more than sufficient given your circumstances.  A way around this would be to place the backend milestones in a near-term position.  Instead of a $300m upfront payment, $100m might be sufficient if the first backend milestone were, for instance, a $40m Phase-2 payment upon first patient dosed.  The prospective partner will be able to tell his or her shareholders that this deal was a steal given the low upfront payment while you’ll be able to tell us that more money will be realized in a shorter period of time.

Letting interested parties know that getting CYC140 into the clinic quickly and onto a large Phase-2 study is of the utmost importance will allow you to get more than what you’ll need.  And an equity raise at a larger market-cap of say $80 to a $100m on news of this deal for CYC065 will add even more operating capital to your reserves.

And finally, it’s important for me to add the following caveat.  Make a break with the past!  Do not play data mining games!  This will only add to an already poor image in the retail investment community and solicit Feuerstein’s added critique.  Reporting the DNA Damage Response data from Phase-2 is fine.  But if that data is, in fact, so-so, let both sapacitabine and seliciclib go.  Focus all of your efforts and communications on the bright future you know in your heart that we possess.

This is the moment that will define you forever.

Always be well…

Michael Webb

Adam Feuerstein Foments Fear Pitching CYCC Into Beggars Hell

I am long, Cyclacel Pharmaceuticals (CYCC).

“The oldest and strongest emotion of mankind is fear, and the oldest and strongest kind of fear is fear of the unknown.”  H. P. Lovecraft – Author

It is no small irony that the Phobos of biotech has demanded that the SEC step in to regulate all other social media voices over the meteoric rise in micro-cap stock prices.  From his dual vantage points on Twitter with over 50 thousand followers, and lofty bully pulpit of The (darkening) Street, it would seem far easier for Adam Feuerstein to see the bigger picture that includes his own disproportionate influence over potential bag holders.  That, however, would require turning his gaze inward a perspective that few urchins of the dark underbelly of Wall Street possess.   It’s not surprising then that uber analyst Feuerstein is equally unwilling to identify the greater and more frequent malady of downside price manipulation that is far easier to accomplish with roughly the same skill set of lies and distortions.

The Hidden Bliss of Willful Ignorance

Now, you can’t foment.  That’s a violation of…  You can’t foment.  You can’t create, yourself, an impression that a stock’s down.  But, you do it anyway because the SEC doesn’t understand it.  So, I mean, that’s the only sense that I would say it’s illegal.  But a hedge fund that’s not up a lot really has to do a lot now to save itself.

Jim Cramer – Executive Editor of The Street

When Feuerstein labelled Cyclacel Pharmaceuticals “a zero” and it’s position holders as “trading worthless pieces of paper” he knew the devastating effects his derogatory commentary would have on the stock price because he’d done the same thing seven months prior, albeit, with several strands of justification and far less fear mongering.  And while these threads hadn’t become fibrous wisps over the course of two changing seasons Feuerstein had to willfully ignore the avalanche of mounting preclinical evidence that was piling up regarding Cyclacel’s Phase-1 CDK2/9 Inhibitor, CYC065, if only because investors weren’t.  Consequently, Feuerstein rummaged through his old articles to solicit a tired narrative about a company that, seemingly, unbeknownst to him was in transformation.  This absence of a fresh perspective frequently substitutes due diligence with a cocky, careless disregard of the present day facts.

Let me state from the outset that I agree with Mr. Feuerstein’s historical assessment of the company and while I would phrase it a bit differently, Cyclacel has been both adept at conducting equity raises and deceptive about the timing of those events.  And their lead drug candidate, sapacitabine, an underpowered nucleotide analog, failed miserably in a late stage trial, the reported outcome of which was delayed whilst the company tapped their ATM agreement for roughly $6.5m in badly needed cash.  It then goes without saying that I’m no fan of Cyclacel’s executive leadership though I have, and do now, own shares.  Fixing one’s sight on past performance alone, however, is no way to navigate the ever changing landscape of a biotechnology equity.

“The ‘Dumb & Dumber’ Cyclacel Investor”

It was in August of 2016 that Feuerstein penned his last article on Cyclacel the title of which referred to equity holders as dumb and dumber.  In my own article entitled: Cyclacel Pharmaceuticals – What You Don’t Know, I didn’t disagree with most of his assessments at least as they pertained to past performance.  And any shareholder that thought sapacitabine’s SEAMLESS trial had more that a lottery ticket chance of success hadn’t read my extensive coverage on Seeking Alpha which included numerous misgivings about apples to oranges comparisons of past trials and the almost ridiculous SPA requirement of a 27.5% beat of decitabine in the active arm.  That noted, I had two strong disagreements with Feuerstein’s presentation.

Firstly, his use of pejoratives to describe corporate executives who lie, cheat and distort information germane to shareholder concerns is forgivable.  I’ve rightfully referred to many of them as psychopaths for shedding one’s conscience seems to be requisite for ascension to the role of CEO.  But calling shareholders “Dumb and Dumber” is another thing altogether.  It’s designed to suspend critical thinking by shaming someone into selling their shares.  When you read a Feuerstein missive on his home base of The Street, you’ll rarely find links to trial studies, SEC documentations or press releases.  He’s long on bloviating and short on information.  And this article was no exception.

Secondly, Feuerstein went only half way down the clinical pipeline and did a poor job of even that.  He continues to ignore the fact that CYC065, Cyclacel’s second generation CDK2/9 Inhibitor has been in a Phase-1 dose escalation study since September of 2015.  In fact, he didn’t mention it at all!  It has now reached the sixth level of dosing without incident and is, according to the company, 40 times more powerful that seliciclib which Feuerstein did deride as “not worth anything”.  Interestingly, it too has been in a Phase-1 study that reported promising results in June of 2016 shortly before Feuerstein wrote his disparaging remarks.  In that trial, seliciclib is combined with sapacitabine to treat patients with advanced solid tumors.  It has since been expanded to treat a specific subgroup of patients that were more amenable to treatment.

Developmental Biotechnology Companies Are Valued By Promise Alone

Immature and struggling enterprises that fail one day often succeed the next after a late stage candidate steps front and center or an altogether new compound is bought and developed.  Regado Biosciences (RGDO) which later became Tobira (TBRA) would be a perfect example of the latter while Cyclacel, with time, might prove itself to be a stunning example of the former.  This is not to say that Tobira ever had a commercial therapeutic.  It didn’t!  That’s the very definition of the word “developmental” – non-commercial.  In fact, its acquired candidate failed a phase-2 study.  But the therapeutic market size was large enough to warrant an approximate $150m market-cap (7x the size of CYCC’s today) and Allergan paid a 500% premium to buy the company on a gamble that it might succeed.  In developmental biotech the word “might” can and often does carry a lofty price tag.

There is a middle ground between possible and probable, between might and maybe, which is occupied by the word plausible and investors appreciate that.  So, when study group after study group added to a mounting pile of evidence suggesting efficacy in one of oncology’s prized MOAs investors logically acknowledged that Cyclacel’s $16m market-cap was woefully low.  A company with a promising CDK2/9-Inhibitor in the top therapeutic landscape of oncology warrants a market-cap far in excess of the one Cyclacel sports today.  After all, Pfizer’s (PFE) CDK-Inhibitor, Ibrance, approved as recently as 2015, is expected to bring in $3.5bn in 2017 revenues.  And once investors made those logical connections, Feuerstein stepped in to quash that awakening.  And he did so in willful violation of SEC rules regarding making false statement to promulgate false impressions.  But why?

Qui Bono?  Who Benefits?

Allow me to state with confidence that Adam Feuerstein holds no positions himself in any of the stocks he writes about.  This provides a veil of objectivity that reinforces the idea of his independence from subjective influence.  It does not, however, mitigate the possibility of external bias.  And this is what people need to consider when Feuerstein renders his harsh verdicts on the equities he covers.  What other people perceive of as courage in his cutting remarks is nothing more from my vantage point than complete indemnification from libel lawsuits afforded to him by his employer.  I’m running a great risk writing this article of ruffling Feuerstein’s plumage and incurring his renowned wrath.  That, however, is a risk that someone, somewhere, and at some time needs to take to stop this manipulation of micro-cap equities from taking place.  I am now ready to take that stand!

To determine a person’s motives we have to ask the question: who benefits from their actions?  I found the appearance of Feuerstein on Benzinga’s Premarket Prep to be extremely enlightening.  The link I posted also contains an audio file in which two Benzinga analysts on BZ TV talk about AF’s earlier remarks.  Here’s a quote from Brent Slava.

So, Adam is probably the top biotech reporter out there. He’s at The Street right now. He has a ton of connections. He’s probably the most connected biotech reporter out there right now. So, he’s a source you absolutely need to listen to if you’re in the biotech space.

So whom, you might ask, is Adam connected to?  Well, for one, hedge fund operators.  His mentor at The Street, Jim Cramer is one of those larger than life personalities that populate the airwaves of the main stream media and got his start in that capacity.  And since many of the editors at Seeking Alpha have come over from The Street and have an array of friendships with prominent hedge fund managers contributing on that platform, you can bet Feuerstein is connected in that way as well.  Feuerstein has hinted at connections with the FDA.  But in the Premarket Prep show, Feuerstein also revealed his connections to investment bankers.  He cautioned that a lot of the micro-cap run-ups in value that we see today are followed by add-on offerings at huge discounts to the going price.  What he didn’t tell you is that a lot of these micro-caps like Cyclacel are deserving of larger market-caps that will give them the more favorable financing terms that they need to remain viable.  Deserving because their pipeline candidates are succeeding and generating a logical response from the investment community.  By capitulating the stock price with falsehoods that foment fear, Feuerstein holds them in bondage to stock purchase and sale agreements that are highly dilutive to shareholder value but do feed the lower end of the investment bank food chain.

What happens when you get caught buying this thing and then the company announces an offering?  You know, you’re caught and then the offering comes in at a discount and you’re caught owning this thing much higher.  So, I think, what I worry about, what I do see is that a lot of people sort of just start making a lot of fundamental justifications for why these stocks deserve to be trading higher.

Adam Feuerstein – Benzinga Premarket Prep – April 5th 2017

Those investors that Feuerstein professes concern for are now caught.  But not because of an offering announced at a discount but because the narrative he created – that the company and stock have no value created a fearful sell-off that has many of them stranded at $8, $9, or even $10 a share.  It could very well be that Feuerstein’s connectedness to biotech companies, investment banks and hedge funds had nothing at all to do with his commentary.  And truthfully, it doesn’t have to!  The commentary itself is what is wrong and stands on its own as the single force driving the downward trajectory of the equity.

Feuerstein is Right!  But for the Wrong Reason

The question also has to be asked: why would Adam use his social media platform on Twitter to tank Cyclacel’s stock rather than allow for a gradual slowing of the upward trend that would have provided access to logical and profitable exit points?  What Feuerstein did was to yell fire in a crowded theater when there wasn’t any.  News, validated by research professionals and presented at respected oncology conferences drove the upward excitement.  And the very investors he claims to be “worried about” are indeed now caught and stranded at those higher price points.  And while Feuerstein seemed to dial back his charges of social media manipulation of Cyclacel’s price on Benzinga’s premarket show, none of the hosts had the courage to ask him why his own remarks, being the most feared voice in biotech, should have fallen out of the reach of his own regulatory concerns.

The SEC should step in and investigate whether or not Feuerstein’s claims that CYCC is “a zero” having no value is anything other than a blatant lie given that Cyclacel in its entire history as a developmental biotech has never been valued at zero.  In fact, over the past 52 weeks, CYCC has been valued at between $3.05 and $10.50 a share.  And while I’ve retained my holdings acquired prior to Feuerstein’s calculated tirade that included those follow on discussions on Benzinga, my position has been damaged as the company’s quest for relevance has been significantly compromised by Feuerstein’s false claim that we “are trading worthless pieces of paper.”

This week will mark the first time in my four year biotech investment career that I will have completed the filing of a SEC complaint against Mr. Feuerstein for blatant stock price manipulation.  It won’t be the first time I’ve seen it.  But, rather, the first time I’ve been directly effected by it.  On Seeking Alpha, for instance, I witnessed two hedge fund managers manipulate the price of a nano-cap biotech equity all while investing millions of dollars in the company.  My investment of $10k in Cyclacel may seem laughable to many of you who read this article.  But I worked 10 to 14 hours a day, 5 to 7 days a week as a bus driver to make that happen.  And each dollar means many times more to me than it will to any hedge fund manager anywhere.

Will it do Any Good?

I doubt it!  You see after hearing Jim Cramer’s very public confession of stock manipulation in the video linked to above, I have resolved that the SEC fully approves of Cramer’s tactics and those of his counterpart on The Street.  The system works for those who belong in jail.  It does not work for hard working, circumspect investors like you and me.

Always be well…

 

Tap, Tap, Tap Cyclacel Does It Again

In an August 22nd article entitled: Cyclacel Pharmaceuticals: What You Don’t Know, I mused upon the motivations behind Andrew Fein’s $173 price target on an equity that was trading for a scant $4.48 on the day prior to publication.  Was this based upon the notion conveyed by Cyclacel’s controversial CEO Spiro Rombotis in a promotional video found here that indicated a slower than expected evolution of the trial since enrollment had closed in December of 2014?  Or was this the precursor to tapping an ATM agreement with FBR Capital Markets & Co struck in June?  The answer came within the Q3 2016 Report, issued on November 14th, which showed that Cyclacel had tapped that agreement for $5m.  That’s right!  $5M.  And then again in October for an additional $1.5m bringing their cash on hand to $19.5m at the time of publication.  This for a company sporting a market-cap today of roughly $17M according to Seeking Alpha and $12m according to Yahoo.  I suspect that the former is more accurate as they’re likely taking into account the added and highly dilutive shares.

I don’t know why I’m susceptible to falling into the retail investor trap that is Cyclacel Pharmaceuticals time and again but I am.  And it’s becoming a very expensive habit.  It’s undoubtedly one of the more difficult stocks to read.  And August 22nd was no exception.  We had Andrew Fein valuing the equity at $60 per share without (SEAMLESS) success.  I too found Cyclacel’s developmental pipeline to be underrated.  And the possibility remains that sapacitabine’s historically long tail at the end of the KM curve could still allow for an epic Hail Mary result but management’s greedy sale of shares tells a different story.  As disappointing as the fire sale has been to the value of our holdings, even more frustrating for me was viewing that video now posted on the Cyclacel website.  Nowhere within the 6m:52s conversation is any mention of the DSMB assessment that the study’s futility boundary had already been crossed indicating a likely failure to meet the 27.5% improvement in overall survival.  That makes the video not only promotional but highly deceptive as well.

At one point in the conversation, the staggeringly uninformed host recaps sapacitabine’s strengths by stating: “So, no more infusion therapy, caregivers are freed up, patients are in-home, um, fantastic technology.”  To which Spiro Rombotis responds: “Well, we think so.”  But there’s a problem.  The sapacitabine only arm was dropped in this trial due to, most likely, lack of efficacy.  The active arm is composed of alternating infusions with decitabine.  Consequently, there would be infusions upon approval and patients would be in home half of the time over the course of their treatment.  The drug could be given on its own but that would be done without proof of efficacy as a standalone therapy.  What bothers me is that Rombotis makes no effort to be forthcoming by correcting the mistaken perception.

If you want a good look at what the hidden hand of ATM dilutions looks like, feast your eyes on this screen grab featuring a typical day’s trading of CYCC.

Note the two large volume spikes just prior to noon and just after 3 PM.  They are most likely the handiwork of a value diluting investment banker and his desperate partner.  And just below is what the Cyclacel chart looked like on the day of Fein’s enthusiastic appraisal and after the ensuing punishment inflicted on us all by way of the ATM agreement.  If you’re wondering why Cyclacel resorted to this retail investor unfriendly method of financing its operations you need only ask yourself who would subscribe to a public offering of a company with a pivotal study that was sure to read out poorly.

Wrapping it up, I’m underwater (again) on CYCC and have no choice but to hold.  The chance of SEAMLESS success is about 100k -1 given the amount of money the company has raised.  I have a small amount of dry powdered that I’d be tempted to wager on the day of published failure but the ATM facility would, no doubt, leap into action were the equity to jump off the floor thereby mitigating any chance I’d have to recover my losses.  And since CYCC’s market-cap has swollen by nearly 50% since before this all began, Fein’s price target would of necessity be cut by at least a third or more.  Therefore, the upside is downsized, though it remains significant.  But only, however, if the company starts to think of its shareholders well being.

Always be well…

Additional disclosure: Any information or opinion expressed herein may not be true, accurate or correct and it does not constitute any 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 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 an investment professional before making any investment decision. Acting on what any one writer, including me has imparted to you is foolish at best. I have no better access to resources or gift of opinion formulation than you do. I sometimes make mistakes. 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 upwards or downwards. These events can be of a wide variety not limited to news-related occurrences, 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, invest at your own considerable risk attaining the just reward your efforts have wrought.