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.
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.
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